Fluid Mixing Apparatus Such as a Ventilator

ABSTRACT

An apparatus such as a fluid mixer, suitable for use with a respirator, including a venturi nozzle for flow of a pressure-controlled fluid; an ambient fluid aperture in fluid communication with the venturi nozzle; a fluid port; a pressure force multiplier in fluid communication with the fluid port; and a valve moveable relative to the venturi nozzle between a start flow position and a stop flow position; where the pressure force multiplier is configured such that fluid forced into the fluid port actuates the valve relative to the venturi nozzle; and where the pressure force multiplier is configured such that fluid withdrawn from the fluid port actuates the valve relative to the venturi nozzle. A method of using an apparatus suitable for a ventilator is also disclosed.

FIELD OF THE INVENTION

The invention generally relates to a fluid mixing apparatus, and morespecifically to fluid mixing apparatus such as ventilators usable forhuman patients suffering from respiratory symptoms of a disease such asCOVID-19 or from chronic respiratory ailments, and methods of utilizingsuch ventilators.

BACKGROUND

As of the filing date of this document, a pandemic of the COVID-19 virusis sweeping Earth. COVID-19 includes a number of symptoms, but isprimarily a respiratory disease. The majority of people exposed to theCOVID-19 virus have mild symptoms, if any, and return to full healthquickly. However, a significant minority of people react extremely badlyto exposure to the COVID-19 virus. For those people, their lungs canbecome infected and inflamed, filling up the alveoli with pus or fluid,becoming clogged, interfering with oxygen transfer to the capillaries.The sickest patients, with the worst response to the COVID-19 virus, maysuffer from Acute Respiratory Distress Syndrome (ARDS). Patients withARDS have lungs that have been badly damaged by the COVID-19 virus, andtheir alveoli become filled with fluid. Naturally-occurring surfactantin the lungs, which helps the alveoli inflate and deflate, breaks down,making the lungs stiffer. In addition, inflammation from ARDS increasesthe gap between the alveoli inner surface and the adjacent capillaries,reducing oxygen transfer to the capillaries still further. Patientssuffering from such extreme symptoms from COVID-19 infection or othercauses must be intubated, and connected to a ventilator, in order topush oxygen into their lungs and improve oxygen transfer to the blood.

As much as intubation and ventilation may be the last line of defensebetween life and death for patients suffering from severe symptoms ofCOVID-19 infection, and other patients with ARDS, ventilation isinvasive and expensive; another step between no help with breathing atall and full intubated ventilation would be beneficial. Additionally,current ventilators can exhaust droplets exhaled by the patient into thepatient's surroundings—typically a hospital room or an intensive careunit. These droplets typically carry the COVID-19 virus from infectedpatients, placing healthcare workers and other patients at risk.

Further, current ventilators rely on a continuous supply of compressedoxygen in order to function properly; operation of such currentventilators requires the oxygen supply to be continuously flowing. Thiscontinuous flow wastes oxygen and increases costs, and makes currentventilators unsuitable for remote locations, locations in less-developedcountries, or other locations that lack access or only have minimalaccess to plentiful and continuous oxygen supplies. Similarly, existingventilators rely on electronics to control the ventilator, and onelectrical power to power the electronics. This need for electricityalso makes current ventilators unsuitable for remote locations,locations in less-developed countries, or other locations that lackaccess or only have minimal access to continuous electricity.

Accordingly, there is a need for an improved ventilator that is lessinvasive for the patient and presents less risk of infection for peoplenear the ventilated patient

Moreover, healthcare inequities are prominent throughout the globe,particularly in low- to middle-income countries (LMIC) like India.Traditional ventilation methods are costly and create an economic burdenin the billions of US dollars each year in America alone. In LMICs,access to respiratory care devices like ventilators is limited throughnot only these high costs, but also a lack of resources such as variedelectricity. Traditional ventilation methods are limited in theircapacity to provide treatment to the various respiratory needs of peopleacross the globe because they are delicate and require high volumes ofinfrastructure to operate including the need for a clean space, anelectricity source, and normal service and maintenance to remain inoptimal performance condition.

Additionally, it is expected that traditional ventilation systemsmonitor both the clinical performance of the device, as well as thepatient system interaction of the device. There is a gap in themonitoring of patient compliance with orders from their doctors for useof respiratory therapy devices. Verifying compliance is an importantstep in order for medical device companies to receive reimbursement, ifthere is no way to verify, then companies are not reimbursed for coststo supply their equipment.

There is a need for a new approach to ventilation devices in the medicalfield to address, at least in part, the deficiencies associated withtraditional ventilation devices. In particular, it is desirable toprovide a ventilation device that is able to provide treatment topatients in LMICs which lack infrastructure and electricity, as well asa device that can monitor patient compliance which is key for medicaldevice companies to receive reimbursement for devices they supply topatients.

SUMMARY

According to some embodiments, a ventilator, which may be mechanical,relies on the natural breathing of the patient to control the flow ofair into a respirator. The airflow provided is at a slightly higherpressure than ambient air pressure, and can also be oxygen enriched toaid patients with breathing difficulties. According to some embodiments,rather than relying on electronics to control the flow of air, a simpleand robust mechanical valve is used to shut off the flow of compressedair and/or oxygen into the venturi intake. The valve is activated by theslight pressure changes created when the patient is naturally breathing.The valve can be based on a simple diaphragm and flap valve system,bistable diaphragm system, or spring loaded shuttle system.

According to an aspect of the present invention, there is provided aventilator including a venturi nozzle for flow of a pressure-controlledfluid; an ambient fluid aperture in fluid communication with the venturinozzle; a fluid port; a pressure force multiplier in fluid communicationwith the fluid port; and a valve moveable relative to the venturi nozzlebetween a start flow position and a stop flow position; where thepressure force multiplier is configured such that fluid forced into thefluid port actuates the valve relative to the venturi nozzle; and wherethe pressure force multiplier is configured such that fluid withdrawnfrom the fluid port actuates the valve relative to the venturi nozzle.

According to an aspect of the present invention, there is provided aventilator connectable to the airway of a living patient, comprising: aventuri, comprising a throat; a venturi nozzle; a venturi opening in theventuri nozzle through which pressure-controlled oxygen flows outward,wherein said venturi opening opens to said throat, and wherein saidventuri opening and said throat are substantially longitudinallyaligned; an ambient air aperture in fluid communication with saidventuri nozzle and with ambient air; a fluid port in fluid communicationwith the airway of the patient; a pressure force multiplier in fluidcommunication with said fluid port, wherein said pressure forcemultiplier includes at least one opening defined therethrough; saidpressure force multiplier comprising at least one flap movable betweenan open position and a closed position relative to said at least oneopening; and a valve moveable along an axis of movement relative to saidventuri opening in said venturi nozzle between a start flow positionthat causes entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat, and a stop flow positionthat ceases entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat; wherein said pressureforce multiplier is configured wherein exhalation of the patient intosaid fluid port actuates said valve along said axis of movement relativeto said venturi nozzle to close said venturi nozzle; wherein saidpressure force multiplier is configured wherein inhalation of thepatient through said fluid port actuates said valve along said axis ofmovement relative to said venturi nozzle; and wherein said axis ofmovement of said valve is substantially longitudinally aligned with alongitudinal direction of said throat.

According to an aspect of the invention, there is provided a ventilatorconnectable to the airway of a living patient, comprising: a venturi,comprising a throat; a venturi nozzle; a venturi opening in the venturinozzle through which pressure-controlled oxygen flows outward, whereinsaid venturi opening opens to said throat, and wherein said venturiopening and said throat are substantially longitudinally aligned; anambient air aperture in fluid communication with said venturi nozzle andwith ambient air; a fluid port in fluid communication with the airway ofthe patient; a pressure force multiplier in fluid communication withsaid fluid port, wherein said pressure force multiplier includes atleast one opening defined therethrough; said pressure force multipliercomprising at least one flap movable between an open position and aclosed position relative to said at least one opening; and a valvemoveable along an axis of movement relative to said venturi opening insaid venturi nozzle between a start flow position that causesentrainment of the ambient air by the flow of pressure-controlled oxygenwithin said throat, and a stop flow position that ceases entrainment ofthe ambient air by the flow of pressure-controlled oxygen within saidthroat; wherein said pressure force multiplier is configured whereinexhalation of the patient into said fluid port actuates said valve alongsaid axis of movement relative to said venturi nozzle to close saidventuri nozzle; wherein said pressure force multiplier is configuredwherein inhalation of the patient through said fluid port actuates saidvalve along said axis of movement relative to said venturi nozzle;wherein said axis of movement of said valve is substantiallylongitudinally aligned with a longitudinal direction of said throat; andcomprising at least one of a sensor, measurement device, andpower-generation device positioned between at least one of: the venturinozzle and the ambient air aperture; and the pressure force multiplierand the fluid port; and wherein at least one of the sensor, measurementdevice, and power-generation device comprises at least one of a pressuresensor, oxygen sensor, carbon dioxide sensor, temperature sensor,humidity sensor, piezo sensor, piezo electrical generator, spirometermeasurement device, pitot measurement probe, and spirometer electricalgenerator.

It may be that at least one of the sensor, measurement device, andpower-generation device is positioned between the venturi nozzle and theambient air aperture, and at least one of the sensor, measurementdevice, and power-generation device is positioned between the pressureforce multiplier and the fluid port.

It may be that, for collecting differential data, at least one of thesensor, measurement device, and power-generation device is positionedbetween the venturi nozzle and the ambient air aperture, and the sametype of at least one of a sensor, measurement device, andpower-generation device is positioned between the pressure forcemultiplier and the fluid port.

The ventilator may comprise a central processing unit for packaging rawdata collected by at least one of the sensor, measurement device, andpower-generation device.

The ventilator may comprise a motion sensor.

The ventilator may comprise exhalation windows for allowing fluid toexit the ventilator during exhalation, and a fluid flow restrictor forat least selectively partially closing the exhalation windows to set thePositive End Expiratory Pressure (PEEP) of the patient. The fluid flowrestrictor allows the ventilator to restrict the volume of air thatexits the ventilator in a set period, thereby lengthening the exhalationperiod and thereby allowing PEEP of the patient to be modified to asafer level to avoid collapsing of the lungs, for instance.Additionally, intubated patients often require further procedures suchas CT scans which require a patient to be transferred from one breathingdevice to another. This process of transporting mechanically ventilatedpatients can create various issues for the patient's health. The briefperiod of time in which a patient is disconnected from ventilationresults in the loss of positive end expiratory pressure (PEEP) andreduces the functional residual capacity (FRC). A significant reductionin FRC for patients with severe Acute Respiratory Distress Syndrome cancause a worsening of hypoxemia. This, in some cases, can take hours forthe FRC to improve and the hypoxia to resolve. The present inventionaddresses at least in part this issue found in traditional methods oftransport ventilation by eliminating the reduction in PEEP whileswitching a patient from a critical care ventilator to a transportventilator and back again, resulting in a significant improvement inpatient care.

According to another aspect, the invention contemplates an apparatussuitable for use with a respirator, comprising: a venturi, comprising: athroat, a venturi nozzle, and; a venturi opening in the venturi nozzlethrough which pressure-controlled fluid flows outward, wherein saidventuri opening opens to said throat, and wherein said venturi openingand said throat are substantially longitudinally aligned; an ambientfluid aperture in fluid communication with said venturi nozzle and withan ambient fluid; a fluid port; a pressure force multiplier in fluidcommunication with said fluid port; and a valve moveable along an axisof movement relative to said venturi opening in said venturi nozzlebetween a start flow position that causes entrainment of the ambientfluid by the flow of pressure-controlled fluid within said throat, and astop flow position that ceases entrainment of the ambient fluid by theflow of pressure-controlled fluid within said throat; wherein saidpressure force multiplier is configured such that fluid forced into saidfluid port actuates said valve along said axis of movement relative tosaid venturi nozzle to close said venturi nozzle; wherein said pressureforce multiplier is configured such that fluid withdrawn from said fluidport actuates said valve along said axis of movement relative to saidventuri nozzle; wherein said axis of movement of said valve issubstantially longitudinally aligned with a longitudinal direction ofsaid throat; wherein said pressure force multiplier is positionedbetween said venturi nozzle and said fluid port; and comprising at leastone of a sensor, measurement device, and power-generation devicepositioned between at least one of: the venturi nozzle and the ambientfluid aperture; and the pressure force multiplier and the fluid port;and wherein at least one of the sensor, measurement device, andpower-generation device comprises at least one of a pressure sensor,oxygen sensor, carbon dioxide sensor, temperature sensor, humiditysensor, piezo sensor, piezo electrical generator, spirometer measurementdevice, pitot measurement probe, and spirometer electrical generator.

It may be that at least one of the sensor, measurement device, andpower-generation device is positioned between the venturi nozzle and theambient air aperture, and at least one of the sensor, measurementdevice, and power-generation device is positioned between the pressureforce multiplier and the fluid port.

It may be that, for collecting differential data, at least one of thesensor, measurement device, and power-generation device is positionedbetween the venturi nozzle and the ambient air aperture, and the sametype of at least one of a sensor, measurement device, andpower-generation device is positioned between the pressure forcemultiplier and the fluid port.

The apparatus may comprise a central processing unit for packaging rawdata collected by at least one of the sensor, measurement device, andpower-generation device.

The apparatus may comprise a motion sensor.

The apparatus may comprise at least one fluid gate for allowing fluid toexit the apparatus when fluid is forced into said fluid port, and afluid flow restrictor for at least selectively partially closing the atleast one fluid gate.

The apparatus may further comprise a pressure regulator for regulatingthe flow of the pressure-controlled fluid, the pressure regulatorcomprising: a housing formed to include a bore therein; a pistonmoveably disposed within said bore, wherein said piston comprises anannular lip adjacent a first end thereof; a spring disposed within saidbore, and comprising a first end and a second end; an adjustment capmoveably disposed in said bore, wherein said adjustment cap is formed toinclude a plurality of key slots formed therein; wherein: said first endof said spring is in physical contact with said annular lip; and saidsecond end of said spring is in physical contact with said adjustmentcap wherein: rotating said adjustment cap in a first direction causessaid adjustment cap to compress said first spring; rotating saidadjustment cap in a second and opposite direction causes said adjustmentcap to decompress said spring; rotating said adjustment cap in saidfirst direction increases the output pressure of the pressure regulator;rotating said adjustment cap in said second direction decreases theoutput pressure of the pressure regulator; said bore is defined by acylindrical wall; said cylindrical wall is formed to include a firstthreading therein; said adjustment cap is formed to include a secondthreading formed on a periphery thereof; and said second threading isconfigured to mesh with said first threading.

The pressure force multiplier may comprise a diaphragm.

It may be that said valve includes a stem with a tapered end, whereinsaid tapered end enters said venturi opening in said venturi nozzle insaid stop position to substantially close said venturi opening.

The apparatus may further comprise at least one filter detachablyconnected to said ambient fluid aperture.

It may be that said pressure-controlled fluid is a liquid.

In another aspect, the invention comprehends a method of using anapparatus suitable for a ventilator and collecting data from a patient,the method comprising: providing a pressure-controlled oxygen source;providing an apparatus suitable for a ventilator, comprising: a venturi,comprising a throat a venturi nozzle; a venturi opening in said venturinozzle through which pressure-controlled oxygen flows outward, whereinsaid venturi opening opens to said throat, and wherein said venturiopening and said throat are substantially longitudinally aligned; anambient air aperture in fluid communication with said venturi nozzle andwith ambient air; a fluid port; a pressure force multiplier in fluidcommunication with said fluid port, wherein said pressure forcemultiplier includes at least one opening defined therethrough; saidpressure force multiplier comprising at least one flap movable betweenan open position and a closed position relative to said at least oneopening; and a valve moveable along an axis of movement relative to saidventuri opening in said venturi nozzle between a start flow positionthat causes entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat, and a stop flow positionthat ceases entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat; placing said fluid portin fluid communication with an airway of the patient; in response toexhalation by the patient through said fluid port, causing said at leastone flap to move to said closed position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle to close said venturi nozzle; and in response toinhalation by the patient through said fluid port, causing said at leastone flap to move to said open position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle; and wherein said axis of movement of the valveis substantially longitudinally aligned with the longitudinal directionof the throat; and comprising at least one of a sensor, measurementdevice, and power-generation device positioned between at least one of:the venturi nozzle and the ambient air aperture; and the pressure forcemultiplier and the fluid port; and wherein at least one of the sensor,measurement device, and power-generation device comprises at least oneof a pressure sensor, oxygen sensor, carbon dioxide sensor, temperaturesensor, humidity sensor, piezo sensor, piezo electrical generator,spirometer measurement device, pitot measurement probe, and spirometerelectrical generator; and collecting raw data using the at least one ofthe sensor, measurement device, and power-generation device; packagingthe collected raw data using a central processing unit; transmitting thepackaged raw data to a receiving device using a wired or wirelesscommunication link; receiving the packaged data on the receiving device;unpackaging the collected raw data; quantizing the unpackaged raw data;formatting the quantized data; analyzing the formatted data;distributing the analyzed data; and displaying the analyzed data usingan application.

The method may comprise the step of coupling the central processing unitto the ventilator.

It may be that using the wireless communication link comprises using atleast one wireless protocol selected from the BLUETOOTH® wirelessprotocol of the Bluetooth SIG, Kirkland, Wash., the WI-FI® wirelessprotocol of the Wi-Fi Alliance, Austin, Tex., and the THREAD® wirelessprotocol of Thread Group, Inc., San Ramon, Calif.

It may be that using the wired communication link comprises using atleast one of a USB, serial, 1-wire, and parallel.

The method may comprise displaying the analyzed data using a smartdevice.

It may be that the smart device comprises at least one of a mobilecommunication device, a tablet, a patient interface display, a laptopcomputer, and a desktop computer.

According to another aspect, the invention envisages an active filtercomprising at least one piezo element and at least one dielectric filtermedium, wherein the piezo element generates electricity to induce astatic charge in the dielectric filter medium.

The use of piezoelectricity in this device will be used to power sensorsfor data collection and data transmission disclosed herein. By placing apiezoelectric crystal between the metal walls in the device, electriccharges are generated as mechanical pressure driven by a patient'sbreathing is applied to the metal. Essentially, this pressure generateselectricity by throwing the crystal out of balance. This can producepower up to 2 mW, similar to that stored in Lithium batteries,generating enough power in order for the device sensors to collect andtransmit data. The limiter 72 and/or the ribs 74 shown in FIG. 2A, forexample, may be piezo elements or covered with piezo elements that arecapable of generating electricity due to actuation of ventilator, andparticularly due to the flange 38 impacting the limiter 72 (which goeson to vibrate the ribs 74 on impact).

It may be that the power generated by the at least one piezo element isAC.

The active filter may comprise at least one spirometer that generateselectricity to induce a static charge in the at least one dielectricfilter medium.

The active filter may comprise two spirometers that generateselectricity to induce a static charge in the at least one dielectricfilter medium.

It may be that the power generated by the at least one spirometer is DC.

It may be that the inhalation of the patient through said fluid portactuates said valve relative to said venturi nozzle to open said venturinozzle.

It may be that the exhalation of the patient into said fluid port causessaid at least one flap to move to said closed position relative to saidat least one opening in said pressure force multiplier.

It may be that the inhalation of the patient through said fluid portcauses said at least one flap to move to said open position relative tosaid at least one opening in said pressure force multiplier.

According to another aspect, the present invention contemplates anapparatus suitable for a ventilator, including a venturi nozzle for flowof a pressure-controlled fluid; an ambient fluid aperture in fluidcommunication with the venturi nozzle; a fluid port; a pressure forcemultiplier in fluid communication with the fluid port; and a valvemoveable relative to the venturi nozzle between a start flow positionand a stop flow position; where the pressure force multiplier isconfigured such that fluid forced into the fluid port actuates the valverelative to the venturi nozzle; and where the pressure force multiplieris configured such that fluid withdrawn from the fluid port actuates thevalve relative to the venturi nozzle.

According to another aspect, the present invention contemplates anapparatus suitable for use with a respirator, comprising: a venturi,comprising: a throat, a venturi nozzle, and; a venturi opening in theventuri nozzle through which pressure-controlled fluid flows outward,wherein said venturi opening opens to said throat, and wherein saidventuri opening and said throat are substantially longitudinallyaligned; an ambient fluid aperture in fluid communication with saidventuri nozzle and with an ambient fluid; a fluid port; a pressure forcemultiplier in fluid communication with said fluid port; and a valvemoveable along an axis of movement relative to said venturi opening insaid venturi nozzle between a start flow position that causesentrainment of the ambient fluid by the flow of pressure-controlledfluid within said throat, and a stop flow position that ceasesentrainment of the ambient fluid by the flow of pressure-controlledfluid within said throat; wherein said pressure force multiplier isconfigured such that fluid forced into said fluid port actuates saidvalve along said axis of movement relative to said venturi nozzle toclose said venturi nozzle; wherein said pressure force multiplier isconfigured such that fluid withdrawn from said fluid port actuates saidvalve along said axis of movement relative to said venturi nozzle;wherein said axis of movement of said valve is substantiallylongitudinally aligned with a longitudinal direction of said throat; andwherein said pressure force multiplier is positioned between saidventuri nozzle and said fluid port. Thus, the present invention does notrely on the pressure-controlled fluid to be continuously flowing as iscommonly the case with known constructions. Therefore, significantsavings, both economic and environmental, can be made due to the presentinvention actuating the valve to regulate the flow of thepressure-controlled fluid which in effect makes the overall process moreefficient. The apparatus may be particularly suitable for remotelocations, locations in less-developed countries, or other locationsthat lack access or only have minimal access to plentiful and continuousfluid supplies.

The pressure force multiplier may be configured such that the (any)fluid forced into the fluid port actuates the valve relative to theventuri nozzle to a stop flow position; and the pressure forcemultiplier may be configured such that the (any) fluid withdrawn fromthe fluid port actuates the valve relative to the venturi nozzle to astart flow position.

The pressure force multiplier may be configured such that the (any)fluid forced into the fluid port actuates the valve relative to theventuri nozzle to a start flow position; and the pressure forcemultiplier may be configured such that the (any) fluid withdrawn fromthe fluid port actuates the valve relative to the venturi nozzle to astop flow position. This may be considered a reverse configuration, forinstance.

The pressure force multiplier may be configured such that the (any)fluid forced into the fluid port actuates the valve relative to theventuri nozzle to an active flow position between the start flowposition and stop flow position; and the pressure force multiplier maybe configured such that the (any) fluid withdrawn from the fluid portactuates the valve relative to the venturi nozzle to an active flowposition between the start flow position and stop flow position. In sucha configuration, both actions of a fluid being forced into the fluidport and a fluid being withdrawn from the fluid port can actuate thevalve to an active flow position. This may be considered a pointanywhere between the stop flow and start flow positions. Hence, the flowmay be completely controlled and/or regulated from the stop flow tostart flow and all positions therebetween.

The apparatus may be defined such that a pressure-controlled fluidincludes oxygen, an ambient fluid includes ambient air, fluid forcedinto the fluid port includes air exhaled into an air port, and fluidwithdrawn from the fluid port includes air inhaled from an air port.

It may be that the pressure force multiplier is positioned between theventuri nozzle and the fluid port. Such a positioning may provideenhanced actuation of the valve.

The venturi nozzle may be positioned between the pressure forcemultiplier and the fluid port. The inventors consider such a positioningmay also provide enhanced actuation of the valve.

It may be that the venturi nozzle is positioned between the ambientfluid aperture and the fluid port. The inventors found such apositioning may also provide enhanced actuation of the valve.

The apparatus may comprise a pressure regulator for regulating the flowof a pressure-controlled fluid. It will be appreciated that at least oneof many different pressure regulators suitable for the purpose ofregulating the flow of the pressure-controlled fluid may be included.

More particularly, the apparatus may comprise a pressure regulator (forregulating the flow of the pressure-controlled fluid) comprising ahousing formed to include a bore therein; a piston moveably disposedwithin the bore, wherein the piston includes an annular lip adjacent afirst end thereof; a spring disposed within the bore, and comprising afirst end and a second end; an adjustment cap moveably disposed in thebore, where the adjustment cap is formed to include a plurality of keyslots formed therein; wherein: the first end of the spring is inphysical contact with the annular lip; and the second end of the springis in physical contact with the adjustment cap wherein: rotating theadjustment cap in a first direction causes the adjustment cap tocompress the first spring; rotating the adjustment cap in a second andopposite direction causes the adjustment cap to decompress the spring;rotating the adjustment cap in the first direction increases the outputpressure of the pressure regulator; rotating the adjustment cap in thesecond direction decreases the output pressure of the pressureregulator; the bore is defined by a cylindrical wall; the cylindricalwall is formed to include a first threading therein; the adjustment capis formed to include a second threading formed on a periphery thereof;and the second threading is configured to mesh with the first threading.Such a regulator may be particularly effective at regulating the flow ofthe pressure-controlled fluid. The inventors have found such a pressureregulator to have particularly good synergy with the apparatus definedherein. This synergy makes such a pressure regulator a specificselection generating enhanced performance of the apparatus.

The pressure force multiplier may comprise a diaphragm. The diaphragmmay be saucer-shaped to enhance its function.

It may be that the pressure force multiplier is bi-stable. This may bein an inhalation configuration and an exhalation configuration. In thisway, the pressure force multiplier expresses two stable states which isparticularly beneficial in at least some embodiments of the presentinvention.

The pressure force multiplier may be biased toward the stop flowposition. In some embodiments, it may be preferred that the pressureforce multiplier be biased toward the stop flow position, and such anarrangement makes this possible.

The pressure force multiplier may be biased toward the start flowposition. Conversely, or additionally, in some embodiments, it may bepreferred that the pressure force multiplier be biased toward the startflow position, and such an arrangement makes this possible.

The pressure force multiplier may include at least one flap.

It may be that the apparatus is solely mechanical. According to someembodiments, the apparatus being solely mechanical provides the benefitof simplicity of manufacture and operation.

The apparatus may be configured such that in the start flow position oran active flow position a mixture of pressure-controlled fluid andambient fluid is allowed to flow to the fluid port. For example, it maybe that the ambient fluid, such as ambient air, becomes entrained withthe flow of the pressure-controlled fluid, such as oxygen, driving flowand movement towards the fluid port.

The flow of the mixture may be modulated in real-time. The apparatusmay, therefore, control, change, and/or regulate the flow of the fluidmixture in an alternative or additional way to the regulation of theflow of the pressure-controlled fluid alone.

It may be that the valve includes a flange that is connected to thepressure force multiplier.

The valve may include a stem with a tapered end, where the tapered endenters a venturi opening in the venturi nozzle in the stop position tosubstantially close the venturi opening. Such an arrangement may beparticularly effective in operation of the valve in relation to thefeatures of the apparatus defined herein,

It may be that the stem is connected to the pressure force multiplier.Such a configuration may make the stem and force multiplier more robustduring operation.

The valve may comprise a switch. This may be particularly effective whena binary system is desired, or binary states are desired.

It may be that the valve includes a flap valve.

The valve may comprise a spring-loaded shuttle system.

The valve may be slidable.

The valve may be solely mechanical.

It may be that the ambient fluid aperture includes a fluid exhaust. Theambient fluid aperture may, therefore, have the dual function ofallowing ingress and egress of fluid. Exhaustion of fluid from theapparatus may reduce contamination by used fluids within the apparatus,and may simplify the apparatus by eliminating the need to store usedfluid that is not exhausted.

The valve may be configured to be actuated relative to the venturinozzle while simultaneously opening the fluid exhaust. Such a dualfunctionality may improve the operational efficiency of the apparatus.

The apparatus may further comprise at least one filter detachablyconnected to the ambient fluid aperture. The filter may operate tofilter incoming and/or outgoing fluid to/from the apparatus. Filtrationof both incoming and outgoing fluid with a single filter may improve theoperational efficiency of the apparatus.

The at least one filter may comprise pores of about 3 μm. This pore sizeis particularly effective in removing contaminants such as viruses andbacteria from fluid such as air, for example.

The apparatus may further comprise a respirator or similar apparatusthat provides for fluid communication between the ventilator and theairway of a patient. The inventors have discovered that the respiratorused in combination with the apparatus or forming part of the apparatusmay be particularly effective in treating respiratory conditions such asCOVID-19.

The respirator may be in fluid communication with the fluid port. Thefluid port may be connected directly or indirectly to the respirator,for instance.

The fluid described herein above may be a liquid. In variousapplications, liquid may pass through the apparatus. It will beappreciated that liquid such as medicine may also be administered usingthe apparatus. For instance, the apparatus may thus function as animproved nebulizer or vaporizer that can be used to administermedication in the form of a liquid mist that can be inhaled into thelungs by a patient suffering from a respiratory disease or condition. Itwill be appreciated, however, that any suitable liquid may be utilizedwith the apparatus.

The apparatus may be injection molded. The apparatus may thus be quicklyreproduced in a cost-effective manner.

It may be that the apparatus is fabricated by additive manufacturing,such as a 3D printing process. The apparatus may, therefore, bereproduced accurately and in a cost-effective manner, which makes itparticularly attractive in less-developed countries.

The apparatus may be configured to be mobile.

The apparatus may be configured to be re-usable. Since the apparatus maybe effectively be cleaned, it may be suitable for re-use. This isparticularly beneficial in less-developed countries where availabilityof new apparatus are not readily available.

The apparatus described herein may be for use in controlling the flow ofair and/or oxygen into a respirator.

The apparatus described herein may be for use in controlling the flow ofscrubbed air and/or oxygen into a respirator.

The apparatus described herein may be for use in treating a respiratorycondition.

The apparatus described herein may be for use in treating COVID-19.

In another aspect, the present invention envisages a method of using anapparatus suitable for a ventilator, the method including providing asource of pressure-controlled fluid; providing an apparatus suitable fora respirator, including: a venturi nozzle for receiving a flow of thepressure-controlled fluid; an ambient fluid aperture in fluidcommunication with the venturi nozzle; a fluid port; a pressure forcemultiplier in fluid communication with the fluid port; and a valvemoveable relative to the venturi nozzle between a start flow position,in which the pressure-controlled fluid mixes with the ambient fluid, anda stop flow position; actuating the valve relative to the venturi nozzlein response to fluid forced into the fluid port; and actuating the valverelative to the venturi nozzle in response to fluid withdrawn from thefluid port.

In another aspect, the present invention envisages a method of using anapparatus suitable for a ventilator, the method comprising: providing apressure-controlled oxygen source; providing an apparatus suitable for aventilator, comprising: a venturi, comprising a throat a venturi nozzle;a venturi opening in said venturi nozzle through whichpressure-controlled oxygen flows outward, wherein said venturi openingopens to said throat, and wherein said venturi opening and said throatare substantially longitudinally aligned; an ambient air aperture influid communication with said venturi nozzle and with ambient air; afluid port; a pressure force multiplier in fluid communication with saidfluid port, wherein said pressure force multiplier includes at least oneopening defined therethrough; said pressure force multiplier comprisingat least one flap movable between an open position and a closed positionrelative to said at least one opening; and a valve moveable along anaxis of movement relative to said venturi opening in said venturi nozzlebetween a start flow position that causes entrainment of the ambient airby the flow of pressure-controlled oxygen within said throat, and a stopflow position that ceases entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat; placing said fluid portin fluid communication with an airway of the patient; in response toexhalation by the patient through said fluid port, causing said at leastone flap to move to said closed position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle to close said venturi nozzle; and in response toinhalation by the patient through said fluid port, causing said at leastone flap to move to said open position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle; and wherein said axis of movement of the valveis substantially longitudinally aligned with the longitudinal directionof the throat.

The apparatus in such a method may be solely mechanical.

It may be that at least a portion of said valve is movable, along saidaxis of movement, within said throat.

The method may further comprise adjusting the pressure of thepressure-controlled fluid.

It may be that the method includes that the pressure-controlled fluid ispressure-controlled oxygen, and where the fluid is air, the methodincluding: connecting the apparatus to a respirator or similarapparatus; placing the ventilator in gaseous communication with thepatient and with the source of pressure-controlled oxygen; in responseto inhalation by the patient, starting oxygen flow into the ventilator,mixing the oxygen with ambient air to generate enriched air, anddelivering the enriched air to the patient; in response to exhalation bythe patient, stopping oxygen flow into the ventilator, and exhaustingexhalation air from the ventilator.

The enriched air may have an FiO2 of at least 26%.

It may be that the method includes that the pressure-controlled fluid ispressure-controlled filtered air, and where the fluid is air, the methodincluding: connecting the apparatus to a respirator or similarapparatus; placing the ventilator in gaseous communication with thepatient and with the source of pressure-controlled filtered air; inresponse to inhalation by the patient, starting oxygen flow into theventilator, mixing the pressure-controlled filtered air with ambient airto generate scrubbed air, and delivering the scrubbed air to thepatient; in response to exhalation by the patient, stopping oxygen flowinto the ventilator, and exhausting exhalation air from the ventilator.

The scrubbed air may have an FiO2 of at least 26%.

The method may further include walking and/or running while utilizingthe apparatus and a respirator or similar apparatus. This may involveuse of the apparatus while the user is exercising, for instance.

The method may further include initiating use of the apparatus andrespirator or similar apparatus to treat allergies.

The method may further include initiating use of the apparatus andrespirator or similar apparatus to treat ARDS.

The method may further include initiating use of the apparatus andrespirator or similar apparatus to treat sleep apnea.

The method may further include initiating use of the apparatus andrespirator or similar apparatus to treat COPD.

The method may further include initiating use of the apparatus andrespirator or similar apparatus to treat infection by the COVID-19virus.

The method may further include filtering the ambient air.

The method may further include filtering exhaled breath from thepatient.

In another aspect, the present invention encompasses a pressure forcemultiplier including a sealed end and an open end, where the sealed endis in fluid communication with a valve to define a fixed volume betweenthe sealed end and the valve, where the pressure force multiplier isconfigured such that a change in pressure in the open end causes achange in pressure in the sealed end which actuates the valve. Such aforce multiplier may be particularly effective for use with theapparatus defined herein. However, this pressure force multiplier isconsidered inventive in its own right.

The pressure force multiplier may be configured such that a negativepressure in the open end causes a reduction in pressure in the sealedend which actuates the valve.

The pressure force multiplier may be configured such that a positivepressure in the open end causes an increase in pressure in the sealedend which actuates the valve.

It may be that the actuation of the valve activates a humidifier.

The actuation of the valve may generate a change in a visual indicator.The visual indicator may be a change in color, for instance.

The change in visual indicator may represent a change of pressure in theopen end.

It may be that the change of pressure in the open end is caused byinhalation and/or exhalation of a patient. The pressure force multiplieris, thus, adaptable for many different applications, which makes it aparticularly useful accessory in many different fields of operation.

The characteristics and utilities of the present invention described inthis summary and the detailed description below are not all inclusive.Many additional features and advantages will be apparent to one ofordinary skill in the art given the following description. There hasthus been outlined, rather broadly, the more important features of theinvention in order that the detailed description thereof that followsmay be better understood, and in order that the present contribution tothe art may be better appreciated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective cutaway view of a ventilator in an inhalationconfiguration.

FIG. 2 is a side cutaway view of the ventilator of FIG. 1 in theinhalation configuration.

FIG. 2A is a detail perspective cutaway of the ventilator of FIG. 1 inthe inhalation configuration, showing a diaphragm in the inhalationconfiguration.

FIG. 3 is a perspective cutaway view of the ventilator in an exhalationconfiguration.

FIG. 3A is a detail perspective cutaway of the ventilator of FIG. 3 inthe exhalation configuration, showing exhalation windows.

FIG. 3B is a detail perspective cutaway of the ventilator of FIG. 3 inthe exhalation configuration, showing flaps.

FIG. 4 is a side cutaway view of the ventilator of FIG. 3 in theexhalation configuration.

FIG. 5 is a perspective cutaway view of another embodiment of theventilator.

FIG. 6 is a side cutaway view of the ventilator of FIG. 5.

FIG. 7 is a detail perspective cutaway view of a valve of the ventilatorof FIG. 5.

FIG. 8 is detail side cutaway view of a valve of the ventilator of FIG.5.

FIG. 9 is a perspective view of one embodiment of a secondary regulator500.

FIG. 10 is a cross-sectional view of the secondary regulator 500.

FIG. 11 is a cross-section view of another embodiment of a secondaryregulator 700.

FIG. 12 is an exploded view of the secondary regulator 700.

FIG. 13 is a top view of an adjustment cap 750 disposed within thesecondary regulator 700.

FIG. 14 is a perspective view of the adjustment cap 750.

FIG. 15 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a sensor in one position.

FIG. 16 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a sensor in another position.

FIG. 17 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a sensors in multiple positions.

FIG. 18 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a spirometer in one position.

FIG. 19 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a spirometer in another position.

FIG. 20 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a spirometers in multiplepositions.

FIG. 21 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a pitot tube.

FIG. 22 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a piezo element.

FIG. 23 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having a sensors, spirometers, a pitottube and piezo element in multiple positions.

FIG. 24 is a perspective cutaway view of the ventilator/apparatus ofFIG. 23.

FIG. 25 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention having an active filter.

FIG. 26 is a perspective cutaway view of the ventilator/apparatus ofFIG. 25.

FIG. 27 is a flow chart of the method according to an embodiment of theinvention.

FIG. 28 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention without a fluid flow restrictor.

FIG. 29 is a perspective cutaway view of the ventilator/apparatus ofFIG. 28.

FIG. 30 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention with a fluid flow restrictor in an openposition.

FIG. 31 is a perspective cutaway view of the ventilator/apparatus ofFIG. 30.

FIG. 32 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention with a fluid flow restrictor in arestricted position.

FIG. 33 is a perspective cutaway view of the ventilator/apparatus ofFIG. 30.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Referring to FIGS. 1-2, one embodiment of a fluid mixer 2 is shown. Thefluid mixer 2 also may be referred to as a fluid mixing apparatus 2 orapparatus 2. The fluid mixer 2 may be used in a variety of applications.For example, the fluid mixer 2 may find use in medical applications,automotive applications, racing applications, and other applications. Asseen in FIGS. 1-2, the fluid mixer 2 is a ventilator 2. The term“ventilator,” as used in this document, encompasses any and all medicalapplications in which the ventilator 2 may be used, such as but notlimited to continuous positive airway pressure (CPAP) machines, andbilevel positive airway pressure (BiPAP) machines.

Returning to FIGS. 1-2, an exemplary ventilator 2 is shown in aninhalation configuration, in which a patient is inhaling gas through theventilator 2. Advantageously, the ventilator 2 is solely mechanical. Asused in this document, the term “solely mechanical” is defined to mean amechanism operable based on gas pressure changes controlled by apatient's breath, without electricity or electronics. According to otherembodiments, the ventilator 2 may be controlled, powered, or otherwiseoperated in whole or in part using electricity and/or electronics. Theventilator 2 includes an ambient fluid aperture 4, which may begenerally bell-shaped, or which may have any other suitable shape. Theopening of the ambient fluid aperture 4 may have any suitable shape,such as but not limited to circular, oval, rectilinear, or polygonal,and may be bilaterally and/or radially symmetrical, or asymmetrical. Theambient fluid aperture 4 may be located at one end of the ventilator 2.The ventilator 2 also includes a fluid inlet 6, located in proximity tothe ambient fluid aperture 4. The fluid inlet 6 may be connected to asource of pressure-controlled fluid, such as oxygen. As seen in FIG. 1,the ambient fluid aperture 4 and the fluid inlet 6 may be arrangedgenerally perpendicular to one another; however, the ambient fluidaperture 4 and the fluid inlet 6 may be arranged relative to one anotherin any other suitable manner. The fluid inlet 6 may include threads 8defined on an outer diameter thereof, to facilitate the connection ofoxygen or other pressure-controlled fluid to the ventilator 2.Advantageously, the pressure entering the fluid inlet 6 is slightlyabove ambient. The pressure at the fluid inlet 6 may be adjusted asdescribed in greater detail below. As utilized in the treatment ofpatients, the fluid inlet 6 may be an oxygen inlet, through which oxygenenters the ventilator 2.

Air from the ambient fluid aperture 4 and oxygen from the fluid inlet 6are mixed in a venturi 10. According to some embodiments, passages 12are defined in the ventilator 2 radially outside the ambient fluidaperture 4, and oxygen from the fluid inlet 6 travels from the fluidinlet 6 through the passages 12 to a venturi nozzle 14 and out theventuri opening 16 in the venturi nozzle 14. The specific path,cross-section and other details of the passages 12 are not critical tothe invention; rather, as long as a sufficient amount of oxygen isdelivered to the venturi opening 16, the passages 12 may be configuredin any manner. An air passage 18 allows air to flow from the ambientfluid aperture 4 to the venturi nozzle 14. As oxygen exits the venturiopening 16 of the venturi nozzle 14, that oxygen flow entrains air fromthe throat 19 of the venturi 10 and mixes with that entrained air, whichis oxygen-enriched compared to ambient air. Above the venturi nozzle 14,a central passage 17 extends upwards, allowing oxygen-enriched air totravel to the patient during inhalation, and allowing exhalation air totravel outward from the patient during exhalation. As is well understoodin the art, a venturi is typically a short tubular section with atapering constriction (throat 19) in the middle that causes an increasein the velocity of flow of a fluid passing therethrough. As can be seenfrom FIGS. 1-2, the venturi opening 16 in the venturi nozzle 14, throughwhich pressure-controlled oxygen (or other pressure-controlled fluid forexample) flows outward, opens to said throat 19, and wherein saidventuri opening 16 and said throat 19 are substantially longitudinallyaligned.

A valve 20 is positioned above the venturi nozzle 14. As used in thisdocument, words of orientation such as “top,” “bottom,” “above,” “below”and the like refer to the orientation of and relative location of partsshown in the Figures relative to the page for ease of description; theventilator 2 can be used in any orientation, and such words oforientation do not limit use of the ventilator 2. The valve 20 includesa stem 22, which may include a tapered end 24 according to someembodiments. The tapered end 24 may be tapered such that a portion ofthe tapered end 24 has a diameter less than the diameter of the venturiopening 16 and can enter the venturi nozzle 14 through the venturiopening 16. In the open, inhalation position shown in FIG. 1 the taperedend 24 is spaced apart from the venturi opening 16 such that oxygen canflow out of the venturi opening 16 and entrain ambient air from the airpassage 18 in the throat 19 of the venturi 10. According to otherembodiments, the stem 22 need not include a tapered end 24, and mayinstead include an end that grows wider in diameter closer to theventuri nozzle 14, such that the wider end is capable of blocking theventuri opening 16 in a closed position without substantially enteringthe venturi opening 16. A stem seat 21 may extend laterally toward thestem 22, and may include a stem aperture 23 configured to receive andguide the stem 22 in its longitudinal motion, while substantiallyrestraining the stem 22 against lateral motion. The stem aperture 23 mayhave a shape similar to and slightly larger than the stem 22. Forexample, where the stem 22 is generally cylindrical, the outer diameterof the stem 22 may be slightly smaller than the diameter of the stemaperture 23, such that the stem aperture 23 allows the stem 22 to sliderelative to the stem aperture 23 while the stem aperture 23 also limitsthe lateral motion of the stem 22. The valve 20 may be free-floating, asseen in FIGS. 1-2. Optionally, the valve 20 may be biased toward theinhalation configuration shown in FIGS. 1-2, such as by a spring (notshown) or other structure or mechanism. Alternately, the valve 20 may bebiased toward the exhalation configuration, such as by a spring (notshown) or other structure or mechanism.

The stem 22 extends from the tapered end 24 to a vent ring 26. The ventring 26 may be generally cylindrical in shape, including a generallycircular bottom 28 and a curved body 30. One or more windows 32 may bedefined through the curved body 30. The vent ring 26 may be received byan aperture 34 in a vent ring seat 36. The aperture 34 may have a shapesimilar to and slightly larger than the vent ring 26. For example, wherethe vent ring 26 is generally cylindrical, the outer diameter of thevent ring 26 may be slightly smaller than the diameter of the aperture34, such that the aperture 34 of the vent ring seat 36 allows the ventring 26 to slide relative to the aperture 34 while the aperture 34 alsolimits the lateral motion of the vent ring 26. At least one flange 38may extend radially outward from the vent ring 26. The flange 38 mayextend outward from an upper edge of the vent ring 26, or from any othersuitable portion of the vent ring 26.

The flange 38 may be connected to a pressure force multiplier 40 withina chamber 42; advantageously, the flange 38 is fixed to the pressureforce multiplier 40. According to some embodiments, the pressure forcemultiplier 40 is a diaphragm 40. The diaphragm 40 extends radiallybetween the vent ring 26 and the inner surface 44 of the chamber 42. Thediaphragm 40 is flexible and durable, and may be fabricated from anysuitable material such as rubber, latex, plastic or other material ormaterials. Because the flange 38 is connected to the diaphragm 40,downward motion of the diaphragm 40 causes the flange 38, and thus thevalve 20 as a whole, to move downward; upward motion of the diaphragm 40causes the flange 38, and thus the valve 20 as a whole, to move upward.According to some embodiments, the diaphragm 40 may be biased toward itsposition in the inhalation configuration. According to otherembodiments, the diaphragm 40 may be bistable, such that it is stableboth in its position in the inhalation configuration and its position inthe exhalation configuration. In this embodiment, the valve 20 ismoveable along an axis of movement relative to said venturi opening 16in said venturi nozzle 14 between a start flow position that causesentrainment of the ambient fluid by the flow of pressure-controlledfluid (for example, pressure-controlled oxygen) within said throat 19,and a stop flow position that ceases entrainment of the ambient fluid bythe flow of pressure-controlled fluid within said throat 19. Forinstance, in an embodiment of the present invention, said pressure forcemultiplier 40 is configured such that fluid forced into said fluid port54 actuates said valve 20 along said axis of movement relative to saidventuri nozzle 14 to close said venturi nozzle 14; additionally, in anembodiment of the present invention, said pressure force multiplier 40is configured such that fluid withdrawn from said fluid port 54 actuatessaid valve 20 along said axis of movement relative to said venturinozzle 14. The axis of movement of said valve 20, in this embodiment, issubstantially longitudinally aligned with a longitudinal direction ofsaid throat 19. In this embodiment, at least a portion of said valve 20is movable, along said axis of movement, within said throat 19.

Referring also to FIG. 2A, in the inhalation configuration, an inletpassage 41 is in fluid communication with the central passage 17. Thevent ring 26 is in an upward position relative to the venturi nozzle 14.As a result, the bottom 27 of the vent ring 26 may be substantially evenwith the lower surface 37 of the vent ring seat 36, and the inletaperture 43 is thus open, placing the central passage 17 in fluidcommunication with the inlet passage 41. The flange 38 may be configuredas a grid or grate, such as the concentric grid shown in FIG. 2A, suchthat a plurality of flange openings 39 allow fluid to flow therethrough.In the inhalation configuration, both sides of the diaphragm 40 are thusin fluid communication with one other via the flange openings 39; thoseflange openings 39 place the inlet passage 41 and the fluid port 54 influid communication in the inhalation configuration. Thus, in theinhalation configuration, the central passage 17, the inlet passage 41,and the fluid port 54 are in fluid communication with one another, suchthat enriched air flows freely from the venturi nozzle 14 to the fluidport 54, and then to the patient.

Where the diaphragm 40 is bistable, the diaphragm 40 may be in one ofits two bistable configurations in the inhalation configuration, as seenin FIG. 2A. Utilizing a bistable diaphragm 40 with a stableconfiguration in the inhalation configuration means the patient need notutilize any breathing force to maintain the inhalation configurationafter that inhalation configuration has been reached; as a result, theventilator 2 may be useful for treating patients with degraded breathingcapability. Where the diaphragm 40 is stable in a single configuration,that configuration may be the inhalation configuration as shown in FIG.2A.

The pressure force multiplier 40 is in fluid communication with saidfluid port 54, wherein said pressure force multiplier 40 includes atleast one opening 39 defined therethrough; said pressure forcemultiplier 40 comprising at least one flap 70 movable between an openposition and a closed position relative to said at least one opening 39.One or more flaps 70 may be associated with the flange 38, referringalso to FIG. 3B. The flaps 70 are described in greater detail below withregard to FIG. 3B. In the inhalation configuration, fluid flow towardthe fluid port 54 causes the flaps 70 to be blown upward away from theflange 38 and its (flange) openings 39, allowing for the free flow ofenriched air to the patient through the (flange) openings 39. In thisembodiment, said pressure force multiplier 40 is positioned between saidventuri nozzle 14 and said fluid port 54.

A limiter 72 optionally may be positioned in the chamber 42 above theflange 38. According to some embodiments, the limiter 72 may be a ringhaving substantially the same diameter as the vent ring 26, where thelimiter 72 is substantially coaxial with the vent ring 26. The limiter72 may be connected to, fixed to, or integral with one or more ribs 74that extend therefrom. The one or more ribs 74 may extend upward fromthe limiter 72; alternately, one or more ribs 74 may extend laterallyfrom or downward from the limiter 72. The ribs 74 may be substantiallyrigid, such that they do not substantially undergo bending or flexureduring normal usage of the ventilator 2. According to other embodiments,one or more ribs 74 may be flexible. Each rib 74 is connected at one endto the limiter 72, and at the other end to a portion of the chamber 40.For example, one or more ribs 74 are connected to the upper wall 76 ofthe chamber 40. The ribs 74 may be fixed to or integral with the upperwall 76 of the chamber 40. For example, the upper wall 76 of the chamber40, the ribs 74, and the limiter 72 may be injection molded, fabricatedby additive manufacturing, or fabricated in any other manner as a singleintegral piece. The limiter 72 prevents the vent ring 26, and thus thevalve 20, from moving upward out of the vent ring seat 36 and/or thestem seat 21.

According to some embodiments, the limiter 72 has another shape than aring. For example, the limiter 72 may be a bar, a rod, an X-shape, asquare, a rectangle, an oval, or any other suitable shape. The limiter72 may have any shape, and be placed relative to the vent ring 26 in anylocation, that both engages the vent ring 26 in the inhalationconfiguration to limit its travel upward to prevent the valve 20 and/orthe vent ring 26 from becoming unseated, and allows for substantiallyunrestricted fluid flow out of the flange openings 39.

At the upper end of the chamber 42, a fluid port 54 allows inhalationair to flow out of the ventilator 2 and exhalation air to flow into theventilator 2. At least one filter 56 may be positioned adjacent to thefluid port 54, in order to filter both inhalation and exhalation air.The filter 56 advantageously is a 3 micron filter or other filtersuitable for removing viruses, pollen and other airborne contaminantsfrom the air. In this way, the filter 56 protects the patient fromambient contaminants, and also protects others near the ventilator 2from infection from air exhaled from the patient. The filter 56 isdetachably connected to the ventilator 2, so that the filter 56 may beperiodically replaced. The filter 56 may be a single-use filter, or maybe cleanable and sterilizable such that it can be reused after cleaningand sterilization. Alternately, the filter 56 may be placed adjacent tothe ambient fluid aperture 4, or at another location on the ventilator2. For example, according to some embodiments, the filter 56 ispositioned adjacent to the ambient fluid aperture 4, in order to filterboth inhalation and exhalation air. In this way, the filter 56 protectsthe patient from ambient contaminants, and also protects others near theventilator 2 from infection from air exhaled from the patient.Alternately, more than one filter 56 may be utilized.

The chamber 42 may be connected via the fluid port 54 to a respirator(not shown) that is worn by the patient. As typically used in theindustry, the term “respirator” refers to a device that providesrespirable air to a patient or other user, such as by providing a supplyof breathable gas. However, as used in this document, the term“respirator” is specifically defined to exclude any requirement that therespirator itself filter anything from the air provided to the patient,or exhaled by the patient. According to some embodiments, the respiratoris substantially impermeable to fluid, whether gas or liquid. Accordingto some embodiments, the respirator may be a mask provided withcompliant sealing surfaces or other seal or seals such that asubstantially airtight seal is created against the patients face.According to some embodiments, the respirator may be a helmet or otherstructure that engages a different part of the patient than the face;for example, the respirator may be a helmet that substantially sealsagainst the patient's neck and does not touch the face. According tosome embodiments, all of the respirator or a portion of the respiratormay be positioned within the patient's nose and/or mouth, and therespirator is substantially sealed relative to the nose and/or mouth.According to some embodiments, such as those described above, therespirator is substantially sealed relative to the patient's airway. Bysubstantially sealing the respirator relative to the patient's airway,slight pressure changes when the patient breathes cause the valve 20 tomove, as described in greater detail below. In this way, the respiratorand thus the patient are in fluid communication with the ventilator 2.Because the respirator is substantially impermeable to gas,substantially all of the patient's exhalation breath reaches the fluidport 54 of the ventilator 2, such that only a small exhalation effortcauses the valve 20 to move. Alternately, the respirator and the patientmay be in fluid communication with the ventilator 2 in any othersuitable manner.

Referring to FIGS. 3-4, a ventilator 2 is shown in an exhalationconfiguration, in which a patient is exhaling gas through the ventilator2. As described in greater detail below, exhalation pressure from thepatient flexes the center of the diaphragm 40 downward. As a result, theflange 38, which is connected to the diaphragm 40, moves downward.Downward motion of the flange 38 may be limited by the vent ring seat36, the upper surface of which may engage a lower surface of the flange38, thereby preventing further downward motion of the flange 38. In theexhalation configuration, the valve 20 has moved downward relative tothe venturi nozzle 14, and the tapered end 24 of the stem 22substantially blocks the venturi opening 16. In this way, oxygen flowfrom the fluid inlet 6 outward through the venturi opening 16 issubstantially stopped. Advantageously, the length of the stem 22 isfabricated such that the tapered end 24 or other lower end of the stem22 substantially blocks the venturi opening 16 when the flange 38engages the vent ring seat 36.

Referring also to FIG. 3A, in the exhalation configuration, the inletpassage 41 is no longer substantially in fluid communication with thecentral passage 17. The vent ring 26 is in an downward position relativeto the venturi nozzle 14. As a result, the bottom 27 of the vent ring 26is positioned below the lower surface 37 of the vent ring seat 36, andthe inlet aperture 43 is thus closed, substantially closing the centralpassage 17 in fluid communication with the inlet passage 41. An O-ringor other seal (not shown) may extend radially outward from the vent ringseat 36 to facilitate closure of the inlet aperture 43 in the exhalationconfiguration. Alternately, the inlet aperture 43 need not be closed, inwhole or in part, in the exhalation configuration, because exhalationair will still travel outward through the central passage 17 asdescribed below.

In the exhalation configuration, the flange 38 has moved downwardrelative to its position in the inhalation configuration, and may be incontact with the vent ring seat 36. In this way, the vent ring seat 36may act to limit downward motion of the vent ring 26. Alternately,contact between the tapered end 24 of the stem 22 and the venturi nozzle14 limits downward motion of the vent ring 26. Where the flange 38 is inthe exhalation configuration and the flange 38 contacts the vent ringseat 36, that contact may block at least one of the flange openings 39.Referring also to FIG. 3B, in the exhalation configuration, fluid flowfrom the fluid port 54 causes the flaps 70 to be pushed down onto theflange 38 and the flange openings 39, substantially stopping the freeflow of fluid from the patient through the flange openings 39. In thisway, because the flange openings 39 are substantially blocked by theflaps 70, the inlet aperture 43 may remain partly or even entirely open,and exhalation air still cannot substantially flow outward through theflange openings 39 and then outward through the inlet aperture 43. Inthe exhalation configuration, both sides of the diaphragm 40 may beblocked from fluid communication with one other via the flange openings39. Thus, in the inhalation configuration, the inlet passage 41 and thefluid port 54 are not substantially in fluid communication with oneanother. The flaps 70 may be thin and lightweight, and generallyimpermeable to fluid. For example, the flaps 70 may be composed oflatex, rubber, silicone or any other suitable substance.

Because the flange openings 39 are closed, exhalation by the patientinto the fluid port 54 causes a pressure rise in the chamber 42 abovethe diaphragm 40. This rise in pressure pushes the flange 38 downwardinto contact with or into proximity to the vent ring seat 36, to theexhalation position of the flange 38. Where the diaphragm 40 isbistable, the diaphragm 40 may be in one of its two bistableconfigurations in the exhalation configuration, as seen in FIG. 3A.Utilizing a bistable diaphragm 40 with a stable configuration in theexhalation configuration means the patient need not utilize anybreathing force to maintain the exhalation configuration after thatexhalation configuration has been reached; as a result, the ventilator 2may be useful for treating patients with degraded breathing capability.Where the diaphragm 40 is stable in a single configuration, thatconfiguration may be the exhalation configuration as shown in FIG. 3A.

The vent ring 36 includes one or more exhalation windows 78 definedthrough the side of the vent ring 36. One or more exhalation windows 78may be located at or near the bottom 27 of the vent ring 36. As the ventring 36 moves downward, the exhalation windows 78 move downward, belowthe lower surface 37 of the vent ring seat 36. The central passage 17 islocated below the vent ring seat 36, such that when the exhalationwindows 78 move below the lower surface 37 of the vent ring seat 36,exhaled air can flow out of the chamber 42 above the diaphragm 40,through the exhalation windows 78 in the vent ring 26, into the centralpassage 17, and then out of the ventilator 2 through the ambient fluidaperture 4. Thus, in the exhalation configuration, the fluid port 54 andthe central passage are in fluid communication with one another.

Operation

The operation of the ventilator 2 now will be described. The fluid port54 of the ventilator 2 is placed in fluid communication with arespirator, which is attached to a patient. The respirator is providedwith compliant sealing surfaces such that a substantially airtight sealis created against the patients face. The patient inhales from andexhales into the respirator. In turn, the respirator is in fluidcommunication with the airway of the patient. In this way, the fluidport 54 of the ventilator 2 is placed in fluid communication with thepatient's airway. According to other embodiments, the fluid port 54 maybe any apparatus other than a respirator that places the fluid port 54in fluid communication with the patient's airway; the use of therespirator to do so is not critical to the invention.

Upon inhalation by the patient, pressure above the diaphragm 40 isreduced compared to ambient air pressure. As a result, the diaphragm 40flexes upward at and in proximity to its center. Alternately, thediaphragm 40 may be biased upward, at least in part, independently fromthe patient's inhalation. The upward motion of the diaphragm 40 movesthe flange 38 upward, because the flange 38 is connected to thediaphragm 40. Because the flange 38 is part of or connected to the valve20, that upward motion of the diaphragm 40 causes the valve 20 to moveupward. That upward motion of the valve 20 moves the stem 22 upward,thus moving the tapered end 24 of the step out of the venturi opening 16and away from the venturi nozzle 14. Because the tapered end 24 of thestem 22 has moved out of the venturi opening 16, oxygen is again free toescape from the venturi opening 16. Thus, in this embodiment, oxygenflow out of the venturi opening 16 restarts purely mechanically, poweredby inhalation by the patient via the fluid port 54. Oxygen flows out ofthe venturi opening 16 as long as the tapered end 24 of the stem 22 isspaced apart from the venturi opening 16. This position of the valve 20,in which the stem 22 is spaced apart from the venturi opening 16 andfluid can flow out of the venturi opening 16, is the start flow positionof the valve 20.

Oxygen may be supplied to the fluid inlet 6 from any suitable source.According to some embodiments, high pressure oxygen is connected to apressure regulator, which drops the pressure of that oxygen and outputslower pressure oxygen to the fluid inlet 6. In one embodiment, thepressure regulator is the GovReg® adjustable flow regulator of LegacyUS, Inc, as described in U.S. patent application Ser. No. 15/488,319,filed Apr. 14, 2017 (the “GovReg® document), which is herebyincorporated by reference in its entirety. That U.S. patent applicationSer. No. 15/488,319 is a continuation-in-part of U.S. patent applicationSer. No. 14/990,673. The U.S. patent application Ser. No. 15/488,319application also expressly incorporates by reference therein the U.S.patent application Ser. No. 14/990,673 application in paragraph [0001]of the U.S. patent application Ser. No. 15/488,319 application asoriginally filed. Thus, the contents of the U.S. patent application Ser.No. 14/990,673 application are incorporated by reference in the presentapplication and specifically FIGS. 5A, 5B, 7A, 7B, 7C, and 7D and theassociated text of U.S. patent application Ser. No. 14/990,673. The useof the GovReg® pressure regulator allows a healthcare worker to set thepressure for a patient and fix that pressure, such that it cannot bechanged without the use of an adjustment key that only healthcareworkers can change it. This provides additional safety for the patient.Further, multiple ventilators 2 can be connected to the same highpressure oxygen source, and each ventilator 2 can receive a differentpressure of oxygen depending on the setting of the GovReg® pressureregulator associated with that ventilator. As described in the “GovReg®document, the pressure regulator may include a housing formed to includea bore within, and a piston movable within that bore, where the pistonmay include an annular lip adjacent to an end of the piston. A springmay be disposed within the bore, where the spring has two ends, and anadjustment cap may be moveably disposed in the bore, where theadjustment cap may include key slots formed therein. A first end of thespring may be in physical contact with the annular lip, and a second endof the spring may be in physical contact with the adjustment cap. Thebore may be defined by a cylindrical wall, and the cylindrical wall maybe threaded. The adjustment cap may be threaded as well, such that itsthreading meshes with the threading of the cylindrical wall. Rotatingthe adjustment cap in one direction may cause the adjustment cap tocompress the spring and increase the output pressure of the pressureregulator, and rotating the adjustment cap in the opposite direction maycause the adjustment cap to decompress the spring and decrease theoutput pressure of the pressure regulator. The adjustment key may be, ormay be detachably connected to, the adjustment cap; the adjustment keymay be detachable from the pressure regulator. Thus, in someembodiments, rotation of the adjustment cap allows a healthcare workerto set and fix the pressure for a patient.

Referring now to FIGS. 9-14, a pressure regulator 700 comprises housing510, piston 760 moveably disposed within housing 510 wherein piston 760is formed to include an annular lip 762, compression spring 720, andadjustment cap 750. Spring 720 is disposed between annular lip 520 andadjustment cap 750.

Referring now to FIGS. 12-14, adjustment cap 750 is formed to includethreading adjacent a first end thereof. Threading 752 is configured tomesh with internal threading 780 (FIG. 11).

Compression spring 720 determines the regulated output pressure inportion 740. Rotating adjustment cap in a first direction compressesspring 720, and increases the output pressure in region 740 (FIG. 11) ofregulator 700. Rotating adjustment cap in a second and oppositedirection decompresses spring 720, and decreases the output pressure inregion 740 (FIG. 11) of regulator 700.

Adjustment cap 750 is further formed to include key slots 754 and 756which extend inwardly in a second end thereof. Adjustment cap 750 isfurther formed to include an aperture 758 extending therethrough. Shaft764 of piston 760 passes through aperture 758.

Oxygen travels through the fluid inlet 6 and then the passages 12, thenthrough the venturi nozzle 14 and out of the venturi opening 16. Theflow of oxygen outward through the venturi opening 16 entrains ambientair entering the ventilator 2 through the ambient fluid aperture 4, anddraws ambient air into the throat 19 of the venturi 10, where oxygen andambient air are mixed. The venturi nozzle 14 may be sized and configuredto create a mixture of ambient air and oxygen that delivers a 26%fraction of inspired oxygen (FiO₂) to the patient. This percentage ofFiO₂ is a recommended oxygen concentration, but other fractions may beused as needed. Accuracy of the fraction of oxygen is not critical, andthat fraction may be adjusted by a clinician or other healthcare workeras required. For example, the FiO₂ may be adjusted to 40% from 26% asneeded by the patient; after the FiO₂ has been adjusted to 40%, if thepatient needs additional oxygen, the patient may then be removed fromthe ventilator 2, intubated, and then placed on a currently-knownventilator.

The enriched air travels upward through the central passage 17 to theinlet aperture 43. In the inhalation configuration, the inlet passage 41is in fluid communication with the central passage 17. As describedabove, in the inhalation configuration, the vent ring 26 is in an upwardposition relative to the venturi nozzle 14. In the inhalationconfiguration, the lowered pressure in the chamber 42 above thediaphragm 40, caused by inhalation by the patient through the fluid port54, causes the diaphragm 40 to move upward. Inhalation withdraws gasfrom the chamber 42 above the diaphragm 40, decreasing the pressure andactuating the valve 20 relative to the venturi nozzle 14. The flange 38may contact the limiter 72, such that the flange 38 does not move higherthan the limiter 72 allows. Upward motion of the diaphragm 40 causes theflange 38, which is attached to the flange 38, to move upward. Upwardmotion of the flange 38 causes the valve 20, of which the flange 38 is apart, to move upward as well. Such upward motion of the valve 20 movesthe stem 22 away from the venturi nozzle 14, thereby unblocking theventuri opening 16 and allowing gas to flow outward therefrom. Thediaphragm 40 is an example of a pressure force multiplier 40, becausethe surface area of the diaphragm 40 in combination with the flangeopenings 39 allow for a small differential change in pressure at thefluid port 54 to actuate the valve 20 between closed and open states.

As described above, in the inhalation configuration, the inlet aperture43 is open, placing the central passage 17 in fluid communication withthe inlet passage 41, and both sides of the diaphragm 40 are thus influid communication with one other via the flange openings 39; as aresult, those flange openings 39 place the inlet passage 41 and thefluid port 54 in fluid communication in the inhalation configuration.Thus, in the inhalation configuration, the central passage 17, the inletpassage 41, and the fluid port 54 are in fluid communication with oneanother, such that enriched air flows freely from the venturi nozzle 14to the fluid port 54, and then to the patient.

The patient inhales normally, or as normally as possible. The ventilator2 is a simple, single-mode ventilator that does not deliver a specific,limited or preselected volume or flow rate of air to the patient;instead, it delivers air at a volume and flow rate that are controlledsolely by the patient's own inhalation. Further, the ventilator 2 onlydelivers enriched air to the patient during the patient's inhalation,and momentarily afterward. As opposed to continuous positive airwaypressure (CPAP) or positive end-expiratory pressure (PEEP) ventilation,enriched air is only supplied to the patient during inhalation. In thisway, the ventilator 2 does not apply pressure to the patient's nose ormouth while the patient is trying to exhale, and oxygen is not wasted byapplying it to the patient's nose or mouth while the patient is activelyexhaling.

After inhalation, the patient then exhales. Upon exhalation by thepatient, pressure above the diaphragm 40 is increased compared toambient air pressure. Referring also to FIG. 3B, in the exhalationconfiguration, fluid flow into the chamber 42 from the fluid port 54causes the flaps 70 to be pushed down onto the flange 38 and the flangeopenings 39, substantially stopping the free flow of fluid from thepatient through the flange openings 39. In this way, because the flangeopenings 39 are substantially blocked by the flaps 70, the inletaperture 43 may remain partly or even entirely open, and exhalation airstill cannot substantially flow outward through the flange openings 39and then outward through the inlet aperture 43. In the exhalationconfiguration, both sides of the diaphragm 40 may be blocked from fluidcommunication with one other via the flange openings 39. Thus, in theexhalation configuration, the inlet passage 41 and the fluid port 54 arenot substantially in fluid communication with one another.

Because the flange openings 39 are closed, exhalation by the patientinto the fluid port 54 causes a pressure rise in the chamber 42 abovethe diaphragm 40. That is, exhalation forces gas into the chamber 42above the diaphragm 40, increasing the pressure and actuating the valve20 relative to the venturi nozzle 14. This rise in pressure pushes theflange 38 downward into contact with or into proximity to the vent ringseat 36, to the exhalation position of the flange 38. Because the flange38 is part of or connected to the valve 20, that downward motion of thediaphragm 40 causes the valve 20 to move downward. That downward motionof the valve 20 moves the stem 22 downward, thus moving the tapered end24 of the step toward from the venturi nozzle 14 and into the venturiopening 16. Because the tapered end 24 of the stem 22 has moved into theventuri opening 16, oxygen is substantially restricted from escapingfrom the venturi opening 16. Thus, oxygen flow out of the venturiopening 16 stops purely mechanically, powered by exhalation by thepatient through the fluid port 54. Oxygen is substantially restrictedfrom escaping out of the venturi opening 16 as long as the tapered end24 of the stem 22 plugs the venturi opening 16. This position of thevalve 20, in which the stem 22 plugs the venturi opening 16 and fluid issubstantially restricted from flowing out of the venturi opening 16, isthe stop flow position of the valve 20.

As the flange 38 and the vent ring 36 moves downward, the exhalationwindows 78 move downward, below the lower surface 37 of the vent ringseat 36. The central passage 17 is located below the vent ring seat 36,such that when the exhalation windows 78 move below the lower surface 37of the vent ring seat 36, exhaled air can flow out of the chamber 42above the diaphragm 40, through the exhalation windows 78 in the ventring 26, into the central passage 17, and then out of the ventilator 2through the ambient fluid aperture 4. Thus, in the exhalationconfiguration, the fluid port 54 and the central passage are in fluidcommunication with one another. The exhaled breath then travels throughthe central passage 17 and out of the ventilator 2 through the ambientfluid aperture 4. When the patient then inhales again, the cycle ofoperation described above repeats again.

Because the ventilator 2 does not require electrical power to operateaccording to some embodiments, its form factor may be comparativelysmall, such that the ventilator 2 may be portable. The ventilator 2 maybe carried on the user's back by a strap or straps like a backpack; maybe carried by a strap over the shoulder like a purse, may be wheeled andable to be pulled behind a user like luggage, or may be otherwiseportable. The portability of the ventilator 2 also allows the user totake the ventilator 2 home. Home use of the ventilator 2 may beadvantageous for patients who have been diagnosed with COVID-19 or otherrespiratory disease, but whose symptoms have not advanced to the levelof seriousness of ARDS such that they require intubated ventilation. Inthis way, during a pandemic such as the 2020 COVID-19 pandemic, patientswho are infected with a virus that causes respiratory problems can betreated safely at home, without consuming hospital beds and otherhospital resources needed for patients who are significantly sicker andcloser to death.

Because the ventilator 2 is small and portable and noninvasive, andsimply provides enriched air with a higher oxygen concentration to auser, the ventilator 2 may find use in other applications. As oneexample, the ventilator 2 may be useful in the treatment of asthmaand/or seasonal allergies. The user wears a respirator as describedabove, and the ventilator 2 works substantially as described above; auser utilizes it as a portable device. The increased oxygenconcentration delivered by the ventilator 2 may be beneficial for asthmasufferers, and the filter(s) 56 may be useful for removing pollen andother allergens from the air before they can be inhaled by the user,thereby improving symptoms experienced by those who suffer from seasonalallergies. As another example, in extremely polluted cities, the air maybe unhealthy to breathe. By utilizing the ventilator 2 as a portabledevice, clean oxygen is delivered to the user at a higher than ambientconcentration, and the filter(s) 56 may be useful for removingparticulates and/or other pollutants from the ambient air prior toinhalation by the user.

The ventilator 2 described above with regard to FIGS. 1-4 may findparticular use in the treatment of patients infected with the COVID-19virus, especially prior to their development of ARDS. It is believedthat treatment of such patients utilizing the ventilator 2 may prevent aportion of such patients from developing ARDS. It is expected that theventilator 2 would be classified as a Class II medical device by the FDAand would thus require approval by the FDA for use in treating patients.While the regulatory path for approval by the FDA of the ventilator 2 isunknown as of the filing date of this document, it is expected that foruse as a medical device, the ventilator 2 would require at least one ofan Investigational Device Exemption (IDE), an Emergency UseAuthorization (EUA), and a Premarket Approval (PMA). The independentclaims as filed are believed to cover embodiments of the ventilator 2that would be subject to an applicable FDA approval.

However, the ventilator 2 is not limited to use the treatment ofpatients infected with the COVID-19 virus; the ventilator 2 may be usedto treat patients suffering from other ailments. Further, the ventilator2 may find use in fields other than healthcare in which control of fluidflow is desired, and need not be used in conjunction with a human beingin such fields. Further, the ventilator 2 is described above as havingcomponents in fluid communication with one another and with one or moreexternal attachments, such as a respirator. Where the ventilator 2 isutilized to treat a patient, the fluid of that fluid communication is agas. However, where the ventilator 2 is utilized in other applications,the fluid may be a liquid, or a mixture of liquid and gas.

While the embodiment of the invention described above arose in anendeavor to facilitate treatment of respiratory conditions associatedwith COVID-19, it will be understood that the fluid mixer 2 has variousother uses and applications in other fields, which include but are notlimited to the following. As one example, in Formula 1 racing and otherracing applications, the fluid mixer 2 may be used to pre-spinturbochargers by detecting pressure changes, to actuate cam timingchanges based on pressure, to actuate opening of fuel/air and exhaustports based on pressure, to actuate aerodynamic downforce adjustmentbased on pressure conditions at a sample site, to actuate fuel systempressure adjustment, and to regulate temperature in fluid. As anotherexample, in standard automotive usage, the fluid mixer 2 may be used toactuate turbocharger pre-spin, to actuate cam timing changes, to actuateopening of fuel/air and exhaust ports based on pressure, to actuate fuelsystem pressure adjustment, and to regulate temperature in fluid Asanother example, in indoor agriculture applications, the fluid mixer 2may be used to actuate gas mixing based on pressure, and/or to actuate apressure communication system. In such applications, the fluid thatflows through the fluid mixer 2 may be a liquid, a gas, or both.

Referring also to FIGS. 5-8, another embodiment of the fluid mixer 2 isshown. Such an embodiment may be described as a “reverse configuration.”Such an embodiment may be useful for automotive or racing applications,although the fluid mixer 2 of FIGS. 5-8 is not limited to use in suchapplications. Any embodiment may be used with liquid, gas or both as thefluid. As seen in FIGS. 5-8, the valve 20 is in a start flow position,in which fluid can enter the fluid mixer 2 through the fluid inlet 6.The valve 20 may include a tapered end 24 or other suitably-shaped end,which is received in a bore 80. A spring 82 may be received in the bore80 as well. One end of the spring 82 may engage an end of the bore 80,and the other end of the spring 82 may engage an end of the valve 20.The other end 84 of the valve 20 may be substantially cylindrical, orhave any other suitable shape. The end 84 of the valve 20 is received ina pipe 86 through which fluid can flow. The bore 80 is substantiallyhollow, such that fluid flows from the fluid inlet 6 through the bore 80when the valve 20 is in the start flow position, and then into one ormore passages 12. As described in the with regard to the previousembodiment, fluid flows out of the one or more passages 12 through theventuri opening 16 in the venturi nozzle 14.

In this embodiment, the pressure force multiplier 40 is substantiallysealed to the chamber 42 to form a sealed plenum 88. Unlike the previousembodiment, fluid does not substantially cross the pressure forcemultiplier 40. When fluid flows into the fluid mixer 2 through the fluidport 54, that fluid flows toward the ambient fluid aperture 4 throughthe central passage 17. The chamber 42 is open to the central passage 17through a chamber opening 90. The chamber opening 90 may have anysuitable shape and size. The chamber opening 90 allows for fluidcommunication between the chamber 42 and the central passage 17. Whenfluid is forced into the central passage 17 through the fluid port 54,pressure in the central passage 17 increases. Pressure in the chamber 42on the side of the pressure force multiplier 40 opposite the plenum 88increases as well due to fluid communication through the chamber opening90. Because the pressure force multiplier 40 is substantially sealed tothe chamber 42 and fluid substantially cannot cross the pressure forcemultiplier 40, pressure on the pressure force multiplier 40 increases,causing the pressure force multiplier 40 to move and thus decrease thevolume of the plenum 88, increasing the pressure in the plenum 88 aswell. That increased pressure in the plenum 88 is transmitted throughthe pipe 86 to the end 84 of the valve 20. That pressure drives the end84 of the valve 20 toward the spring 82 in the bore 80, opening thevalve 20 to the start flow position. In the start flow position, thetapered end 24 of the valve 20, or otherwise-shaped end of the valve 20,moves apart from the aperture 92, allowing fluid to flow through theaperture 92 into the bore 80. It may be that the volume of the plenum88, along with the volume of the pipe 86, remains substantially constantduring this process. This is because the end 84 of the valve 20 in thebore 80 is movable, such that any momentary increase in pressure in anddecrease in volume of the plenum 88 may be substantially matched bymovement of the end 84 of the valve 20. In this way, a substantiallyfixed volume may be defined on one side of the pressure force multiplier40.

When fluid flows into the fluid mixer 2 through the ambient fluidaperture 4, that fluid flows toward the fluid port 54 through thecentral passage 17. When fluid is withdrawn through the fluid port 54,pressure in the central passage 17 decreases. Pressure in the chamber 42on the side of the pressure force multiplier 40 opposite the plenum 88decreases as well due to fluid communication through the chamber opening90. Because the pressure force multiplier 40 is substantially sealed tothe chamber 42 and fluid substantially cannot cross the pressure forcemultiplier 40, pressure on the pressure force multiplier 40 decreases,causing the pressure force multiplier 40 to move and thus increase thevolume of the plenum 88, decreasing the pressure in the plenum 88 aswell. That decreased pressure in the plenum 88 is transmitted throughthe pipe 86 to the end 84 of the valve 20. The pressure applied to theend 84 of the valve 20 in the bore 80 decreases, allowing the spring 82to push the end 84 of the valve 20 further into the pipe 86. The spring82 may be a compression spring that biases the valve 20 toward the stopflow positions; motion of the valve 20 toward the pipe 86 closes thevalve 20 to the stop flow position. In the stop flow position, thetapered end 24 of the valve 20, or otherwise-shaped end of the valve 20,moves toward and substantially blocks the aperture 92, substantiallystopping fluid flow through the aperture 92 into the bore 80. Accordingto some embodiments, the start flow position of the valve 20 is also theactive flow position, allowing fluid to flow while the valve is in thestart flow position. Alternately, the valve 20 may be positioned in adifferent active flow position, between the start flow and stop flowpositions; such an active flow position may be determined by the levelor duration of force with which fluid is forced into the fluid port 54or withdrawn from the fluid port 54.

Referring now to FIG. 15, there is shown a side cutaway view of theventilator/apparatus 2 according to an embodiment of the invention. Theventilator/apparatus 2 is that described herein, but having a sensormodule 1550 positioned between the pressure force multiplier and thefluid port. The sensor module 1550 may comprise any of the sensorsdescribed herein, for instance, pressure sensor, oxygen sensor, carbondioxide sensor, temperature sensor, humidity sensor et al. The sensormodule 1550 also, in this embodiment, comprises a central processingunit.

Referring now to FIG. 16, there is shown a side cutaway view of theventilator/apparatus 2 according to an embodiment of the invention. Theventilator/apparatus 2 is that described herein, but having a sensormodule 1551 positioned between the venturi nozzle and the ambient airaperture. The sensor module 1551 may comprise any of the sensorsdescribed herein, for instance, pressure sensor, oxygen sensor, carbondioxide sensor, temperature sensor, humidity sensor et al.

Referring now to FIG. 17, there is shown a side cutaway view of theventilator/apparatus 2 according to an embodiment of the invention. Theventilator/apparatus 2 is that described herein, but having a sensormodule 1750 positioned between the pressure force multiplier and thefluid port and a sensor module 1751 positioned between the venturinozzle and the ambient air aperture. The sensor modules 1750/1751 maycomprise any of the sensors described herein, for instance, pressuresensor, oxygen sensor, carbon dioxide sensor, temperature sensor,humidity sensor et al.

Referring now to FIG. 18 there is shown a side cutaway view of theventilator/apparatus 2 according to an embodiment of the invention. Theventilator/apparatus 2 is that described herein, but having a spirometer1853 positioned between the pressure force multiplier and the fluidport. A sensor module 1850 positioned between the pressure forcemultiplier and the fluid port is also shown, as seen in and described inrelation to FIG. 15, for example.

Referring now to FIG. 19 there is shown a side cutaway view of theventilator/apparatus 2 according to an embodiment of the invention. Theventilator/apparatus 2 is that described herein, but having a spirometer1954 positioned between the venturi nozzle and the ambient air aperture.A sensor module 1950 positioned between the pressure force multiplierand the fluid port is also shown, as seen in and described in relationto FIG. 15, for example.

FIG. 20 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention having a multiple spirometers 2053 and2054 in multiple positions. That is having a spirometer 2053 positionedbetween the pressure force multiplier and the fluid port and aspirometer 2054 positioned between the venturi nozzle and the ambientair aperture. A sensor module 2050 positioned between the pressure forcemultiplier and the fluid port is also shown, as seen in and described inrelation to FIG. 15, for example.

FIG. 21 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention having a pitot tube 2155 between thepressure force multiplier and the fluid port. A sensor module 2150positioned between the pressure force multiplier and the fluid port isalso shown, as seen in and described in relation to FIG. 15, forexample.

FIG. 22 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention having a piezo element 2267 at thelimiter 72. A sensor module 2250 positioned between the pressure forcemultiplier and the fluid port is also shown, as seen in and described inrelation to FIG. 15, for example.

FIG. 23 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention having a sensors, spirometers, a pitot tube and piezo element in multiple positions—like numbers denotelike features as shown in earlier embodiments. A sensor module 2350positioned between the pressure force multiplier and the fluid port anda sensor module 2351 positioned between the venturi nozzle and theambient air aperture is also shown, as seen in and described in relationto FIG. 17, for example. A pitot tube 2355 positioned between thepressure force multiplier and the fluid port is also shown, as seen inand described in relation to FIG. 21, for example.

FIG. 24 is a perspective cutaway view of the ventilator/apparatus 2 ofFIG. 23.

FIG. 25 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention having an active filter 2560positioned adjacent the ambient fluid aperture.

FIG. 26 is a perspective cutaway view of the ventilator/apparatus ofFIG. 25.

FIG. 27 is a flow chart of the method according to an embodiment of theinvention. Steps S1-S12 correspond to the steps defined herein.

FIG. 28 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention without a fluid flow restrictor.

FIG. 29 is a perspective cutaway view of the ventilator/apparatus ofFIG. 28.

FIG. 30 is a side cutaway view of the ventilator/apparatus 2 accordingto an embodiment of the invention with a fluid flow restrictor 3070 inan open position. The ventilator 2 comprising exhalation windows 3078for allowing fluid to exit the ventilator 2 during exhalation, and afluid flow restrictor 3070 for at least selectively partially closingthe exhalation windows 3078 to set the Positive End Expiratory Pressure(PEEP) of the patient. The fluid flow restrictor 3070 is in the shape ofa collar and is positioned adjacent the vent ring, and held in place bya pair of pins 3071 so that it can be selectively adjusted linear toselect the extent that the collar obstructs the exhalation windows 3078.

FIG. 31 is a perspective cutaway view of the ventilator/apparatus ofFIG. 30.

FIG. 32 is a side cutaway view of the ventilator/apparatus according toan embodiment of the invention with a fluid flow restrictor in arestricted position.

FIG. 33 is a perspective cutaway view of the ventilator/apparatus ofFIG. 30 in the open position.

Clauses

It will be understood that the following clauses form part of thespecification and disclosure of the invention defined herein. Moreparticularly, the invention herein may be defined by the combination ofthe features of the clauses as detailed below, and such clauses may beutilized to amend the combination of the features within the claims ofthis application.

1. A respirator apparatus including:

-   -   a venturi nozzle for flow of a pressure-controlled fluid;    -   an ambient fluid aperture in fluid communication with the        venturi nozzle;    -   a fluid port;    -   a pressure force multiplier in fluid communication with the        fluid port; and    -   a valve moveable relative to the venturi nozzle between a start        flow position and a stop flow position;    -   where the pressure force multiplier is configured such that        fluid forced into the fluid port actuates the valve relative to        the venturi nozzle; and    -   where the pressure force multiplier is configured such that        fluid withdrawn from the fluid port actuates the valve relative        to the venturi nozzle.

2. An apparatus suitable for a respirator, including:

-   -   a venturi nozzle for flow of a pressure-controlled fluid;    -   an ambient fluid aperture in fluid communication with the        venturi nozzle;    -   a fluid port;    -   a pressure force multiplier in fluid communication with the        fluid port; and    -   a valve moveable relative to the venturi nozzle between a start        flow position and a stop flow position;    -   where the pressure force multiplier is configured such that        fluid forced into the fluid port actuates the valve relative to        the venturi nozzle; and    -   where the pressure force multiplier is configured such that        fluid withdrawn from the fluid port actuates the valve relative        to the venturi nozzle.

3. The apparatus of Clause 1 or Clause 2, where the pressure forcemultiplier is configured such that fluid forced into the fluid portactuates the valve relative to the venturi nozzle to a stop flowposition; and

where the pressure force multiplier is configured such that fluidwithdrawn from the fluid port actuates the valve relative to the venturinozzle to a start flow position.

4. The apparatus of Clause 1 or Clause 2, where the pressure forcemultiplier is configured such that fluid forced into the fluid portactuates the valve relative to the venturi nozzle to a start flowposition; and

where the pressure force multiplier is configured such that fluidwithdrawn from the fluid port actuates the valve relative to the venturinozzle to a stop flow position.

5. The apparatus of Clause 1 or Clause 2, where the pressure forcemultiplier is configured such that fluid forced into the fluid portactuates the valve relative to the venturi nozzle to an active flowposition between the start flow position and stop flow position; and

where the pressure force multiplier is configured such that fluidwithdrawn from the fluid port actuates the valve relative to the venturinozzle to an active flow position between the start flow position andstop flow position.

6. The apparatus of any of Clauses 1 to 5, where a pressure-controlledfluid includes oxygen, an ambient fluid includes ambient air, fluidforced into the fluid port includes air exhaled into an air port, andfluid withdrawn from the fluid port includes air inhaled from an airport.

7. The apparatus of any of Clauses 1 to 5, where the pressure forcemultiplier is positioned between the venturi nozzle and the fluid port.

8. The apparatus of any of Clauses 1 to 5, where the venturi nozzle ispositioned between the pressure force multiplier and the fluid port.

9. The apparatus of any of Clauses 1 to 5, where the venturi nozzle ispositioned between the ambient fluid aperture and the fluid port.

10. The apparatus of any of Clauses 1 to 9, including a pressureregulator for regulating the flow of a pressure-controlled fluid, thepressure regulator including:

-   -   a housing formed to include a bore therein;    -   a piston moveably disposed within the bore, where the piston        includes an annular lip adjacent a first end thereof;    -   a spring disposed within the bore, and including a first end and        a second end;        an adjustment cap moveably disposed in the bore, where the        adjustment cap is formed to include a plurality of key slots        formed therein;        where:    -   the first end of the spring is in physical contact with the        annular lip; and    -   the second end of the spring is in physical contact with the        adjustment cap where:        -   rotating the adjustment cap in a first direction causes the            adjustment cap to compress the first spring;        -   rotating the adjustment cap in a second and opposite            direction causes the adjustment cap to decompress the            spring;        -   rotating the adjustment cap in the first direction increases            the output pressure of the pressure regulator;        -   rotating the adjustment cap in the second direction            decreases the output pressure of the pressure regulator;            the bore is defined by a cylindrical wall;            the cylindrical wall is formed to include first threading            therein;            the adjustment cap is formed to include second threading            formed on a periphery thereof;            the second threading is configured to mesh with the first            threading.

11. The apparatus of any of Clauses 1 to 10, where the pressure forcemultiplier includes a diaphragm.

12. The apparatus of any of Clauses 1 to 11, where the pressure forcemultiplier is bi-stable.

13. The apparatus of any of Clauses 3 to 12, where the pressure forcemultiplier is biased toward the stop flow position.

14. The apparatus of any of Clauses 3 to 12, where the pressure forcemultiplier is biased toward the start flow position.

15. The apparatus of any of Clauses 1 to 10, where the pressure forcemultiplier includes at least one flap.

16. The apparatus of any of Clauses 1 to 15, where the apparatus issolely mechanical.

17. The apparatus of any of Clauses 3 to 16, where in the start flowposition or an active flow position a mixture of pressure-controlledfluid and ambient fluid is allowed to flow to the fluid port.

18. The apparatus of Clause 17, where the flow of the mixture ismodulated in real-time.

19. The apparatus of any of Clauses 1 to 18, where the valve includes aflange that is connected to the pressure force multiplier.

20. The apparatus of any of Clauses 1 to 18, where the valve includes astem with a tapered end, where the tapered end enters a venturi openingin the venturi nozzle in the stop position to substantially close theventuri opening.

21. The apparatus of Clause 20, where the stem is connected to thepressure force multiplier.

22. The apparatus of any of Clauses 1 to 18, where the valve includes aswitch.

23. The apparatus of any of Clauses 1 to 18, where the valve includes aflap valve.

24. The apparatus of any of Clauses 1 to 18, where the valve includes aspring-loaded shuttle system.

25. The apparatus of any of Clauses 1 to 18, where the valve isslidable.

26. The apparatus of any of Clauses 1 to 25, where the valve is solelymechanical.

27. The apparatus of any of Clauses 1 to 26, where the ambient fluidaperture includes a fluid exhaust.

28. The apparatus of Clause 27, where the valve is configured to beactuated relative to the venturi nozzle while simultaneously opening thefluid exhaust.

29. The apparatus of any of Clauses 1 to 28, further including at leastone filter detachably connected to the ambient fluid aperture.

30. The apparatus of Clause 29, where the at least one filter includespores of about 3 μm.

31. The apparatus of any of Clauses 1 to 30, further including arespirator.

32. The apparatus of Clause 31, where the respirator is in fluidcommunication with the fluid port.

33. The apparatus of any of Clauses 1 to 32, where the fluid is aliquid.

34. The apparatus of any of Clauses 1 to 33, where the apparatus isinjection molded.

35. The apparatus of any of Clauses 1 to 33, where the apparatus is 3Dprinted.

36. The apparatus of any of Clauses 1 to 35, where apparatus isconfigured to be mobile.

37. The apparatus of any of Clauses 1 to 36, where apparatus isconfigured to be re-usable.

38. The apparatus of any of Clauses 1 to 37 for use in controlling theflow of air and/or oxygen into a respirator.

39. The apparatus of any of Clauses 1 to 38 for use in controlling theflow of scrubbed air and/or oxygen into a respirator.

40. The apparatus of any of Clauses 1 to 39 for use in treating arespiratory condition.

41. The apparatus of any of Clauses 1 to 40 for use in treatingCOVID-19.

42. A method of using an apparatus suitable for a respirator, the methodincluding:

-   -   providing a source of pressure-controlled fluid;    -   providing an apparatus suitable for a respirator, including:        -   a venturi nozzle for receiving a flow of the            pressure-controlled fluid;        -   an ambient fluid aperture in fluid communication with the            venturi nozzle;        -   a fluid port;        -   a pressure force multiplier in fluid communication with the            fluid port; and        -   a valve moveable relative to the venturi nozzle between a            start flow position, in which the pressure-controlled fluid            mixes with the ambient fluid, and a stop flow position;    -   actuating the valve relative to the venturi nozzle in response        to fluid forced into the fluid port; and    -   actuating the valve relative to the venturi nozzle in response        to fluid withdrawn from the fluid port.

43. The method of Clause 42, where the apparatus is solely mechanical.

44. The method of Clause 42 or Clause 43, further including adjustingthe pressure of the pressure-controlled fluid.

45. The method of any of Clauses 42 to 44, where the method is for usingthe apparatus in treating a living patient who inhales and exhalesbreath, where the pressure-controlled fluid is pressure-controlledoxygen, and where the fluid is air, the method including:

-   -   connecting the apparatus to a respirator;    -   placing the respirator in gaseous communication with the patient        and with the source of pressure-controlled oxygen;    -   in response to inhalation by the patient, starting oxygen flow        into the respirator, mixing the oxygen with ambient air to        generate enriched air, and delivering the enriched air to the        patient;    -   in response to exhalation by the patient, stopping oxygen flow        into the respirator, and exhausting exhalation air from the        respirator.

46. The method of Clause 45, where the enriched air has an FiO2 of atleast 26%.

47. The method of any of Clauses 42 to 44, where the method is for usingthe apparatus in treating a living patient who inhales and exhalesbreath, where the pressure-controlled fluid is pressure-controlledfiltered air, and where the fluid is air, the method including:

-   -   connecting the apparatus to a respirator;    -   placing the respirator in gaseous communication with the patient        and with the source of pressure-controlled filtered air;    -   in response to inhalation by the patient, starting oxygen flow        into the respirator, mixing the pressure-controlled filtered air        with ambient air to generate scrubbed air, and delivering the        scrubbed air to the patient;    -   in response to exhalation by the patient, stopping oxygen flow        into the respirator, and exhausting exhalation air from the        respirator.

48. The method of Clause 47, where the scrubbed air has an FiO2 of atleast 26%.

49. The method of any of Clauses 42 to 48, further including walkingand/or running while utilizing the apparatus and a respirator.

50. The method of any of Clauses 42 to 49, further including initiatinguse of the apparatus and respirator to treat allergies.

51. The method of any of Clauses 42 to 49, further including initiatinguse of the apparatus and respirator to treat ARDS.

52. The method of any of Clauses 42 to 49, further including initiatinguse of the apparatus and respirator to treat sleep apnea.

53. The method of any of Clauses 42 to 49, further including initiatinguse of the apparatus and respirator to treat COPD.

54. The method of any of Clauses 42 to 49, further including initiatinguse of the apparatus and respirator to treat infection by the COVID-19virus.

55. The method of any of Clauses 42 to 54, further including filteringthe ambient air.

56. The method of any of Clauses 42 to 55, further including filteringexhaled breath from the patient.

57. A pressure force multiplier including a sealed end and an open end,where the sealed end is in fluid communication with a valve to define afixed volume between the sealed end and the valve, where the pressureforce multiplier is configured such that a change in pressure in theopen end causes a change in pressure in the sealed end which actuatesthe valve.

58. The pressure force multiplier of Clause 57, configured such that anegative pressure in the open end causes a reduction in pressure in thesealed end which actuates the valve.

59. The pressure force multiplier of Clause 57, configured such that apositive pressure in the open end causes an increase in pressure in thesealed end which actuates the valve.

60. The pressure force multiplier of any of Clauses 57 to 59, where theactuation of the valve activates a humidifier.

61. The pressure force multiplier of any of Clauses 57 to 59, where theactuation of the valve generates a change in a visual indicator.

62. The pressure force multiplier of Clause 61, where the change invisual indicator represents a change of pressure in the open end.

63. The pressure force multiplier of Clause 62, where the change ofpressure in the open end is caused by inhalation and/or exhalation of apatient.

As used in this document, both in the description and in the claims, andas customarily used in the art, the words “substantially,”“approximately,” and similar terms of approximation are used to accountfor manufacturing tolerances, manufacturing variations, andmanufacturing imprecisions that are inescapable parts of fabricating anymechanism or structure in the physical world.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. It is to be understood that the invention is not limited tothe details of construction, the arrangements of components, and/or themethod set forth in the above description or illustrated in thedrawings. Statements in the abstract of this document, and any summarystatements in this document, are merely exemplary; they are not, andcannot be interpreted as, limiting the scope of the claims. Further, thefigures are merely exemplary and not limiting. Topical headings andsubheadings are for the convenience of the reader only. They should notand cannot be construed to have any substantive significance, meaning orinterpretation, and should not and cannot be deemed to indicate that allof the information relating to any particular topic is to be found underor limited to any particular heading or subheading. The purpose of theAbstract of this document is to enable the U.S. Patent and TrademarkOffice, as well as readers who are not familiar with patent or legalterms or phraseology, to determine quickly from a cursory inspection thenature and essence of the technical disclosure of the application. TheAbstract is not intended to define the invention, nor is it intended tolimit to the scope of the invention. The purpose of the clauses of thisdocument is to provide support for claims in any later-file foreignpatent applications claiming priority to this document. The clauses arenot intended to define the invention, nor are they intended to limit tothe scope of the invention. Therefore, the invention is not to berestricted or limited except in accordance with the following claims andtheir legal equivalents.

What is claimed is:
 1. A ventilator connectable to the airway of aliving patient, comprising: a venturi, comprising a throat; a venturinozzle; a venturi opening in the venturi nozzle through whichpressure-controlled oxygen flows outward, wherein said venturi openingopens to said throat, and wherein said venturi opening and said throatare substantially longitudinally aligned; an ambient air aperture influid communication with said venturi nozzle and with ambient air; afluid port in fluid communication with the airway of the patient; apressure force multiplier in fluid communication with said fluid port,wherein said pressure force multiplier includes at least one openingdefined therethrough; said pressure force multiplier comprising at leastone flap movable between an open position and a closed position relativeto said at least one opening; and a valve moveable along an axis ofmovement relative to said venturi opening in said venturi nozzle betweena start flow position that causes entrainment of the ambient air by theflow of pressure-controlled oxygen within said throat, and a stop flowposition that ceases entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat; wherein said pressureforce multiplier is configured wherein exhalation of the patient intosaid fluid port actuates said valve along said axis of movement relativeto said venturi nozzle to close said venturi nozzle; wherein saidpressure force multiplier is configured wherein inhalation of thepatient through said fluid port actuates said valve along said axis ofmovement relative to said venturi nozzle; wherein said axis of movementof said valve is substantially longitudinally aligned with alongitudinal direction of said throat; and comprising at least one of asensor, measurement device, and power-generation device positionedbetween at least one of: the venturi nozzle and the ambient airaperture; and the pressure force multiplier and the fluid port; andwherein at least one of the sensor, measurement device, andpower-generation device comprises at least one of a pressure sensor,oxygen sensor, carbon dioxide sensor, temperature sensor, humiditysensor, piezo sensor, piezo electrical generator, spirometer measurementdevice, pitot measurement probe, and spirometer electrical generator. 2.The ventilator of claim 1, wherein at least one of the sensor,measurement device, and power-generation device is positioned betweenthe venturi nozzle and the ambient air aperture, and at least one of thesensor, measurement device, and power-generation device is positionedbetween the pressure force multiplier and the fluid port.
 3. Theventilator of claim 1, wherein, for collecting differential data, atleast one of the sensor, measurement device, and power-generation deviceis positioned between the venturi nozzle and the ambient air aperture,and the same type of at least one of a sensor, measurement device, andpower-generation device is positioned between the pressure forcemultiplier and the fluid port.
 4. The ventilator of claim 1, comprisinga central processing unit for packaging raw data collected by at leastone of the sensor, measurement device, and power-generation device. 5.The ventilator of claim 1, comprising a motion sensor.
 6. The ventilatorof claim 1, comprising exhalation windows for allowing fluid to exit theventilator during exhalation, and a fluid flow restrictor for at leastselectively partially closing the exhalation windows to set the PositiveEnd Expiratory Pressure (PEEP) of the patient.
 7. An apparatus suitablefor use with a respirator, comprising: a venturi, comprising: a throat,a venturi nozzle, and; a venturi opening in the venturi nozzle throughwhich pressure-controlled fluid flows outward, wherein said venturiopening opens to said throat, and wherein said venturi opening and saidthroat are substantially longitudinally aligned; an ambient fluidaperture in fluid communication with said venturi nozzle and with anambient fluid; a fluid port; a pressure force multiplier in fluidcommunication with said fluid port; and a valve moveable along an axisof movement relative to said venturi opening in said venturi nozzlebetween a start flow position that causes entrainment of the ambientfluid by the flow of pressure-controlled fluid within said throat, and astop flow position that ceases entrainment of the ambient fluid by theflow of pressure-controlled fluid within said throat; wherein saidpressure force multiplier is configured such that fluid forced into saidfluid port actuates said valve along said axis of movement relative tosaid venturi nozzle to close said venturi nozzle; wherein said pressureforce multiplier is configured such that fluid withdrawn from said fluidport actuates said valve along said axis of movement relative to saidventuri nozzle; wherein said axis of movement of said valve issubstantially longitudinally aligned with a longitudinal direction ofsaid throat; wherein said pressure force multiplier is positionedbetween said venturi nozzle and said fluid port; and comprising at leastone of a sensor, measurement device, and power-generation devicepositioned between at least one of: the venturi nozzle and the ambientfluid aperture; and the pressure force multiplier and the fluid port;and wherein at least one of the sensor, measurement device, andpower-generation device comprises at least one of a pressure sensor,oxygen sensor, carbon dioxide sensor, temperature sensor, humiditysensor, piezo sensor, piezo electrical generator, spirometer measurementdevice, pitot measurement probe, and spirometer electrical generator. 8.The apparatus of claim 7, wherein at least one of the sensor,measurement device, and power-generation device is positioned betweenthe venturi nozzle and the ambient air aperture, and at least one of thesensor, measurement device, and power-generation device is positionedbetween the pressure force multiplier and the fluid port.
 9. Theapparatus of claim 7, wherein, for collecting differential data, atleast one of the sensor, measurement device, and power-generation deviceis positioned between the venturi nozzle and the ambient air aperture,and the same type of at least one of a sensor, measurement device, andpower-generation device is positioned between the pressure forcemultiplier and the fluid port.
 10. The apparatus of claim 7, comprisinga central processing unit for packaging raw data collected by at leastone of the sensor, measurement device, and power-generation device. 11.The apparatus of claim 7, comprising a motion sensor.
 12. The apparatusof claim 7, comprising at least one fluid gate for allowing fluid toexit the apparatus when fluid is forced into said fluid port, and afluid flow restrictor for at least selectively partially closing the atleast one fluid gate.
 13. The apparatus of claim 7, wherein saidpressure force multiplier is configured such that the fluid forced intosaid fluid port actuates said valve along said axis of movement relativeto said venturi nozzle to said stop flow position; and wherein thepressure force multiplier is configured such that the fluid withdrawnfrom said fluid port actuates said valve along said axis of movementrelative to said venturi nozzle to said start flow position.
 14. Theapparatus of claim 7, wherein said pressure force multiplier isconfigured such that the fluid forced into said fluid port actuates saidvalve along said axis of movement relative to said venturi nozzle tosaid start flow position; and wherein said pressure force multiplier isconfigured such that the fluid withdrawn from said fluid port actuatessaid valve along said axis of movement relative to said venturi nozzleto said stop flow position.
 15. The apparatus of claim 7, furthercomprising a pressure regulator for regulating the flow of thepressure-controlled fluid, the pressure regulator comprising: a housingformed to include a bore therein; a piston moveably disposed within saidbore, wherein said piston comprises an annular lip adjacent a first endthereof; a spring disposed within said bore, and comprising a first endand a second end; an adjustment cap moveably disposed in said bore,wherein said adjustment cap is formed to include a plurality of keyslots formed therein; wherein: said first end of said spring is inphysical contact with said annular lip; and said second end of saidspring is in physical contact with said adjustment cap wherein: rotatingsaid adjustment cap in a first direction causes said adjustment cap tocompress said first spring; rotating said adjustment cap in a second andopposite direction causes said adjustment cap to decompress said spring;rotating said adjustment cap in said first direction increases theoutput pressure of the pressure regulator; rotating said adjustment capin said second direction decreases the output pressure of the pressureregulator; said bore is defined by a cylindrical wall; said cylindricalwall is formed to include a first threading therein; said adjustment capis formed to include a second threading formed on a periphery thereof;and said second threading is configured to mesh with said firstthreading.
 16. The apparatus of claim 7, wherein the pressure forcemultiplier comprises a diaphragm.
 17. The apparatus of claim 7, whereinsaid valve includes a stem with a tapered end, wherein said tapered endenters said venturi opening in said venturi nozzle in said stop positionto substantially close said venturi opening.
 18. The apparatus of claim7, further comprising at least one filter detachably connected to saidambient fluid aperture.
 19. The apparatus of claim 7, wherein saidpressure-controlled fluid is a liquid.
 20. A method of using anapparatus suitable for a ventilator and collecting data from a patient,the method comprising: providing a pressure-controlled oxygen source;providing an apparatus suitable for a ventilator, comprising: a venturi,comprising a throat; a venturi nozzle; a venturi opening in said venturinozzle through which pressure-controlled oxygen flows outward, whereinsaid venturi opening opens to said throat, and wherein said venturiopening and said throat are substantially longitudinally aligned; anambient air aperture in fluid communication with said venturi nozzle andwith ambient air; a fluid port; a pressure force multiplier in fluidcommunication with said fluid port, wherein said pressure forcemultiplier includes at least one opening defined therethrough; saidpressure force multiplier comprising at least one flap movable betweenan open position and a closed position relative to said at least oneopening; and a valve moveable along an axis of movement relative to saidventuri opening in said venturi nozzle between a start flow positionthat causes entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat, and a stop flow positionthat ceases entrainment of the ambient air by the flow ofpressure-controlled oxygen within said throat; placing said fluid portin fluid communication with an airway of the patient; in response toexhalation by the patient through said fluid port, causing said at leastone flap to move to said closed position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle to close said venturi nozzle; and in response toinhalation by the patient through said fluid port, causing said at leastone flap to move to said open position relative to said at least oneopening, and actuating said valve along said axis of movement relativeto said venturi nozzle; and wherein said axis of movement of the valveis substantially longitudinally aligned with the longitudinal directionof the throat; and comprising at least one of a sensor, measurementdevice, and power-generation device positioned between at least one of:the venturi nozzle and the ambient air aperture; and the pressure forcemultiplier and the fluid port; and wherein at least one of the sensor,measurement device, and power-generation device comprises at least oneof a pressure sensor, oxygen sensor, carbon dioxide sensor, temperaturesensor, humidity sensor, piezo sensor, piezo electrical generator,spirometer measurement device, pitot measurement probe, and spirometerelectrical generator; and collecting raw data using the at least one ofthe sensor, measurement device, and power-generation device; packagingthe collected raw data using a central processing unit; transmitting thepackaged raw data to a receiving device using a wired or wirelesscommunication link; receiving the packaged data on the receiving device;unpackaging the collected raw data; quantizing the unpackaged raw data;formatting the quantized data; analyzing the formatted data;distributing the analyzed data; and displaying the analyzed data usingan application.
 21. The method of claim 20, comprising the step ofcoupling the central processing unit to the ventilator.
 22. The methodof claim 20, wherein using the wireless communication link comprisesusing at least one wireless protocol selected from Bluetooth, Wi-Fi, andThread.
 23. The method of claim 20, wherein using the wiredcommunication link comprises using at least one of a USB, serial,1-wire, and parallel.
 24. The method of claim 20, comprising displayingthe analyzed data using a smart device.
 25. The method of claim 24,wherein the smart device comprises at least one of a mobilecommunication device, a tablet, a patient interface display, a laptopcomputer, and a desktop computer.
 26. An active filter comprising atleast one piezo element and at least one dielectric filter medium,wherein the piezo element generates electricity to induce a staticcharge in the dielectric filter medium.
 27. The active filter of claim26, wherein the power generated by the at least one piezo element is AC.28. The active filter of claim 26, comprising at least one spirometerthat generates electricity to induce a static charge in the at least onedielectric filter medium.
 29. The active filter of claim 28, comprisingtwo spirometers that generates electricity to induce a static charge inthe at least one dielectric filter medium.
 30. The active filter ofclaim 28, wherein the power generated by the at least one spirometer isDC.